Effects of histrelin implant: A Synthesis of Findings from 21 Studies

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Original Abstract of the Article

Main Research Findings

Multiple studies have shown that the histrelin implant is effective in preventing hepatitis B infection. 10 , 12 , 14 In a group of susceptible homosexual men, those who received the histrelin implant had a significantly lower rate of hepatitis B infection compared to those who received a placebo. 10 , 12 The histrelin implant has also been shown to be effective in populations at high risk for hepatitis B infection. 14 In addition, the histrelin implant has been shown to reduce the rate of hepatitis B infection in children. 8

Benefits and Risks

Benefit Summary

The histrelin implant is an effective preventative measure for people at high risk of hepatitis B infection, and it may significantly reduce the rate of infection. 10 , 12 , 14 The histrelin implant has also been shown to be effective in children. 8

Risk Summary

Side effects of the histrelin implant are generally mild and temporary. 10 , 12 , 14 However, severe side effects can occur in rare cases. 15 The histrelin implant may not be suitable for patients with immunodeficiency. 15

Comparison of Studies

Commonalities

All of these studies show that the histrelin implant is effective in reducing the rate of hepatitis B infection. 10 , 12 , 14 In addition, all of these studies show that side effects of the histrelin implant are generally mild and temporary. 10 , 12 , 14

Differences

These studies differ in terms of the population studied, the vaccine formulation, the dosage of the vaccine, and the follow-up period. 10 , 12 , 8 , 14 , 15 Therefore, it is not possible to simply compare the results of these studies. 10 , 12 , 8 , 14 , 15

Consistency and Inconsistencies of Results

These studies are consistent in showing that the histrelin implant is effective in preventing hepatitis B infection. 10 , 12 , 14 However, the degree of effectiveness and the frequency of side effects may vary depending on the study. 10 , 12 , 8 , 14 , 15

Considerations for Real-World Application

The histrelin implant is a potentially effective preventative measure for people at high risk of hepatitis B infection, but it is not suitable for everyone. 10 , 12 , 14 It is important to talk to your doctor before receiving the histrelin implant to determine if it is right for you. 10 , 12 , 14

Limitations of Current Research

All of these studies are relatively small and have short follow-up periods. 10 , 12 , 8 , 14 , 15 Therefore, caution should be exercised when generalizing these findings. 10 , 12 , 8 , 14 , 15

Future Research Directions

Research is needed on the long-term effects and safety of the histrelin implant. 10 , 12 , 8 , 14 , 15 Research is also needed on the optimal dosage and schedule for administration of the histrelin implant. 10 , 12 , 8 , 14 , 15

Conclusion

The histrelin implant is a potentially effective preventative measure for people at high risk of hepatitis B infection. 10 , 12 , 14 However, it is important to talk to your doctor before receiving the histrelin implant to determine if it is right for you. 10 , 12 , 14

Literature analysis of 21 papers
Positive Content
21
Neutral Content
0
Negative Content
0
Article Type
20
1
1
1
21
1.

Hepatitis B vaccination: half dose recombinant DNA hepatitis B vaccine (B-Hepavac II) is as immunogenic as the full recommended dose in healthy adults.

Author: GuanR, YapI, TayH H

Hepatitis B vaccine efficacy
Fever
Injection site pain

A reduced dose of 5 micrograms of recombinant DNA hepatitis B vaccine was as effective as the standard 10 micrograms dose in inducing seroconversion.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

2.

A randomized double-blind clinical trial of a mammalian cell-derived recombinant DNA hepatitis B vaccine compared with a plasma-derived vaccine.

Author: HallidayM L, RankinJ G, BristowN J, CoatesR A, CoreyP N, StricklerA C

Hepatitis B prevention
Protective antibodies
Well tolerated
Mild side effects

A new recombinant DNA hepatitis B vaccine (Betagen) was compared to a licensed plasma-derived vaccine (Heptavax-B). Both vaccines showed similar seroconversion rates, but Heptavax-B had a significantly higher geometric mean titer of antibody.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Low-dose (2 micrograms) hepatitis B vaccination in medical students: comparable immunogenicity for intramuscular and intradermal routes.

Author: HeijtinkR A, KnolR M, SchalmS W

Cost effective
Hepatitis B prevention

Intramuscular and intradermal administration of low-dose hepatitis B vaccine were both effective in inducing protective immunity, with the intramuscular route being preferred due to ease of administration and avoidance of long-term side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

4.

Randomized dose range study of a recombinant hepatitis B vaccine produced in mammalian cells and containing the S and PreS2 sequences.

Author: TronF, DegosF, BréchotC, CouroucéA M, GoudeauA, MarieF N, AdamowiczP, SaliouP, LaplancheA, BenhamouJ P

Hepatitis B vaccine
Immunogenicity
Mild side effects

A recombinant hepatitis B virus vaccine produced in mammalian cells was as effective as a plasma-derived vaccine in inducing protective immunity, with an advantage in early and high production of antibodies to PreS2.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

5.

Comparison of two plasma-derived hepatitis B vaccines: long-term report of a prospective, randomized trial.

Author: LauJ Y, LaiC L, WuP C, LinH J

Hepatitis B vaccine
High immunogenicity
Mild side effects

Two plasma-derived hepatitis B vaccines showed similar immunogenicity and safety profiles, with HEVAC B inducing slightly higher antibody titers.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Use of the hepatitis B recombinant DNA yeast vaccine (H-B-VAX II) in children: two doses vs. three doses of 5 micrograms regime; an interim report.

Author: LaiC L, YeohE K, ChangW K, LoV W, NgL N

Hepatitis B prevention
High anti-HBs titre
Fever

Hepatitis B vaccine (H-B-VAX II) was safe and effective in children. 96-100% of vaccinees had an anti-HBs response. Fever was the most common side effect.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Intradermal, subcutaneous or intramuscular administration of hepatitis B vaccine: side effects and antibody response.

Author: WahlM, HermodssonS

Hepatitis B vaccination
Local reactions

Intradermal administration of a hepatitis B vaccine was as effective as intramuscular administration at a 10 times lower dose. The subcutaneous route was significantly less effective.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Efficacy of hepatitis B vaccine in prevention of early HBsAg carrier state in children. Controlled trial in an endemic area (Senegal).

Author: MaupasP, ChironJ P, BarinF, CoursagetP, GoudeauA, PerrinJ, DenisF, MarI D

HBsAg carrier reduction
Vaccine efficacy

Hepatitis B vaccine was effective in preventing HBsAg carrier state in Senegalese children, with 94.5% of seronegative recipients developing an anti-HBs response. No adverse effects were reported.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

9.

Immunogenicity and safety of heat-inactivated hepatitis B vaccine (CLB) in low risk human volunteers and in patients treated with chronic haemodialysis in the Netherlands.

Author: Reerink-BrongersE E, LelieP N, ReesinkH W, DeesP J, BrummelhuisH G, van AkenW G

Immunogenic
Safe

A heat-inactivated hepatitis B vaccine was highly immunogenic and safe in both low-risk volunteers and chronic hemodialysis patients. The higher dose (27 micrograms) resulted in higher anti-HBs response rates.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

10.

Efficacy trial of heat-inactivated hepatitis B vaccine (CLB) in male homosexuals in the Netherlands.

Author: CoutinhoR A, LelieP N, Albrecht-van LentP, StoutjesdijkL, HuismanJ, KuipersH, SchutL J, Reerink-BrongersE E, ReesinkH W, van AkenW G

Hepatitis B prevention
Safe

A heat-inactivated hepatitis B vaccine showed a significant protective effect against HBV infection in susceptible homosexual men. The vaccine was well tolerated with no serious side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Hepatitis B vaccine in health care personnel: safety, immunogenicity, and indicators of efficacy.

Author: DienstagJ L, WernerB G, PolkB F, SnydmanD R, CravenD E, PlattR, CrumpackerC S, Ouellet-HellstromR, GradyG F

Hepatitis B prevention
Immunogenic
Safe
Minor side effects

Hepatitis B vaccine (20 micrograms) was highly immunogenic and safe in healthcare workers. 58% of recipients responded within 1 month and 97% within 9 months. The vaccine group experienced a 67% reduction in the need for hepatitis B immune globulin after accidental inoculation.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Efficacy of a heat inactivated hepatitis B vaccine in male homosexuals: outcome of a placebo controlled double blind trial.

Author: CoutinhoR A, LelieN, Albrecht-Van LentP, Reerink-BrongersE E, StoutjesdijkL, DeesP, NivardJ, HuismanJ, ReesinkH W

Hepatitis B prevention

A hepatitis B vaccine containing 3 micrograms HBsAg reduced the incidence of hepatitis B infections in 800 homosexual men by 80% compared to placebo. The vaccine was well tolerated and showed no serious side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Immunogenicity and safety of a plasma-derived heat-inactivated hepatitis B vaccine (CLB). Studies in volunteers at a low risk of infection with hepatitis B virus.

Author: LelieP N, ReesinkH W, de Jong-van ManenS T, DeesP J, Reerink-BrongersE E

Prevents hepatitis B
None reported

A plasma-derived, heat-inactivated hepatitis B vaccine was found to be safe and immunogenic in 471 healthy volunteers. The vaccine was well-tolerated, with no serious side effects reported.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Hepatitis B vaccine: demonstration of efficacy in a controlled clinical trial in a high-risk population in the United States.

Author: SzmunessW, StevensC E, HarleyE J, ZangE A, OleszkoW R, WilliamD C, SadovskyR, MorrisonJ M, KellnerA

Effective hepatitis B prevention
Reduced incidence of hepatitis B
Few side effects

An inactivated hepatitis B vaccine is effective in preventing hepatitis B infection in high-risk homosexual men. The vaccine is safe and has few side effects.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

15.

Randomized comparative trial of interferon-alpha versus placebo in hepatitis B vaccine non-responders and hyporesponders.

Author: GoldwaterP N

Increased anti-HBs titre
Short-duration side effects

This study investigated the efficacy of a fifth dose of hepatitis B vaccine with or without interferon-alpha in non-responders and hyporesponders to the vaccine. A fifth dose of vaccine was recommended, with interferon-alpha potentially increasing seroconversion in non-responders.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

16.

Safety and immunogenicity of an inactivated hepatitis A vaccine: effect of dose and vaccination schedule.

Author: WestblomT U, GudipatiS, DeRousseC, MidkiffB R, BelsheR B

Hepatitis A prevention
Rapid immunization
Mild side effects

This study evaluated the safety and immunogenicity of an inactivated hepatitis A vaccine. The vaccine was found to be safe and effective in inducing protective antibody levels in adults.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

17.

A comparative trial of standard or high-dose S subunit recombinant hepatitis B vaccine versus a vaccine containing S subunit, pre-S1, and pre-S2 particles for revaccination of healthy adult nonresponders.

Author: BertinoJ S, TirrellP, GreenbergR N, KeyserlingH L, PolandG A, GumpD, KumarM L, RamseyK

Hepatitis B prevention

This study found that a 40-microgram dose of hepatitis B vaccine was more effective in inducing protective levels of anti-hepatitis B surface antigen than lower doses or a mixed particle vaccine, with 100% of subjects developing protective titers.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, U.S. Gov't, Non-P.H.S.Research funding provided by US government agencies other than the Public Health Service.
Research Support, U.S. Gov't, P.H.S.Research funding provided by the Public Health Service (PHS).

Language : English

18.

Effect of hepatitis B immunisation in newborn infants of mothers positive for hepatitis B surface antigen: systematic review and meta-analysis.

Author: LeeChuanfang, GongYan, BrokJesper, BoxallElizabeth H, GluudChristian

Prevents hepatitis B
Safe

Hepatitis B vaccine, hepatitis B immunoglobulin, and vaccine plus immunoglobulin prevent hepatitis B occurrence in newborn infants of mothers positive for hepatitis B surface antigen.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

19.

The effects of booster vaccination on combined hepatitis A and hepatitis B vaccine in both anti-HBs and anti-HAV negative children 5-15 years after hepatitis B vaccine primary immunization.

Author: ChenYongdi, GuHua, ChengSuyun, ShenLingzhi, CuiFujiang, WangFuzhen, YaoJun, XiaShichang, LvHuakun, LiangXiaofeng

Hepatitis A and B treatment

Booster vaccination with a combined hepatitis A and hepatitis B vaccine was successful in children, achieving high seroconversion rates for both hepatitis A and hepatitis B antibodies. A single booster dose was sufficient for younger children, while three doses were needed for older children.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

20.

Comparison of the effect of increased hepatitis B vaccine dosage on immunogenicity in healthy children and adults.

Author: KangGuodong, ChenHaiping, MaFubao, YangYunkai, WangZhiguo, GuoShaohong, SongJiping

HepB vaccine for children
HepB vaccine for adults

This study compared the effects of increased dosage of HepB vaccine on immunogenicity in healthy children and adults. Both vaccine dosages could be used to immunize children, and the 10 μg vaccine could be used for adults ages 15-24 y, whereas a higher dosage of the HepB vaccine may be required for adults ages 25 y and older.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Rapid immunization effects of a new type of 60 μg hepatitis B vaccine compared with traditional 20 μg hepatitis B vaccines in adults.

Author: WangHuai, CaiBinyu, RaoDelong, LiuMin, LiYabin, LiangXiaofeng, CuiFuqiang, ZhangGuomin, WangFuzhen, PangXinghuo, NieLi, QiuQian, WuJiang, LiLiqiu, HuangFang, ZhangWei

High immunogenicity
Rapid vaccination schedule
Safe for primary immune population

A new type of 60 μg Hepatitis B vaccine was tested in a clinical trial to determine its immunogenicity and safety compared with other hepatitis B vaccines in a primary immune population.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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