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Also known as Modified Process Hepatitis B Vaccine (Experimental), HBVaxPro
Modified Process Hepatitis B Vaccine · 5 trials · 2 indications
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
A seroresponder was a participant with an anti-hepatitis B surface antibody titer \>=10 milli Merck U/mL. The percentage of seroresponders was assessed before and after the challenge dose.
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 7 (1 month after the third dose).
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Day 1 (prior to the first dose) and at Month 9 (1 month after the fourth dose).
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose).
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
| Arm | Type | Description |
|---|---|---|
| HBVAXPRO™ | EXPERIMENTAL | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
| Modified Process Hepatitis B Vaccine in Base Study | EXPERIMENTAL | Participants who received 3 doses of Modified Process Hepatitis B Vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| ENGERIX-B™ Vaccine in Base Study | EXPERIMENTAL | Participants who received 3 doses of ENGERIX-B™ vaccine in the Base Study were eligible to receive a single challenge dose of Modified Process Hepatitis B Vaccine on Day 1 of the Challenge Dose Study |
| Modified process hepatitis B vaccine | EXPERIMENTAL | Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| ENGERIX-B™2 | ACTIVE_COMPARATOR | ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| Modified Process Hepatitis B vaccine 5 μg | EXPERIMENTAL | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| RECOMBIVAX HB™ Hepatitis B Vaccine | ACTIVE_COMPARATOR | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| Modified Process Hepatitis B vaccine 10 μg | EXPERIMENTAL | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| ENGERIX-B® | ACTIVE_COMPARATOR | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 1) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine (Booster Dose). |
| 10 µg ENGERIX-B™ Booster (Group 2) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a dose of 10µg/per 0.5 ml ENGERIX-B™ (Booster Dose) |
| 5 µg Modified Process Hepatitis B Vaccine Booster (Group 3) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine, (Booster Dose). |
| 10 µg ENGERIX-B™ Booster (Group 4) | ACTIVE_COMPARATOR | Participants had previously received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose) during the first year of life outside of the context of the study. During this study, participants received a 10µg/0.5 ml dose of ENGERIX-B™ (Booster Dose). |
| 5 µg Modified Process Hepatitis B Vaccine (Group 5) | EXPERIMENTAL | Participants did not receive a prior vaccination with a hepatitis B vaccine. During the study, participants received a 5µg/0.5 ml dose of Modified Process Hepatitis B Vaccine. |
| Name | Type | Description |
|---|---|---|
| HBVAXPRO™ | BIOLOGICAL | Single 0.5 mL intramuscular dose |
| Modified Process Hepatitis B Vaccine | BIOLOGICAL | Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study |
| Comparator: modified process hepatitis B vaccine | BIOLOGICAL | Modified process hepatitis B vaccine 40 ug/1.0 mL injection in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| Comparator: ENGERIX-B™ | BIOLOGICAL | ENGERIX-B™ two 20 ug/1.0 mL injections in a 4 dose regimen at months 0, 1, 6, and 8. Duration of treatment is 9 months. |
| Modified Process Hepatitis B Vaccine (Experimental) | BIOLOGICAL | Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm). |
| Hepatitis B Vaccine (Recombinant) | BIOLOGICAL | RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months. |
| Comparator: Comparator: ENGERIX-B | BIOLOGICAL | Single dose 10 µg/0.5ml ENGERIX-B |
Inclusion Criteria: * Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator. * Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxe...
Top 6 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Viread, Tenofovir alafenamide |
| Vir Biotechnology, Inc. | VIR | 6 | PHASE3 | Tobevibart, Elebsiran |
| Bausch Health Companies Inc. | BHC | 1 | PHASE3 | Larsucosterol |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Daplusiran/Tomligisiran, Bepirovirsen |
| Aligos Therapeutics, Inc. | ALGS | 1 | PHASE2 | ALG-000184 |
| Precision BioSciences, Inc. | DTIL | 2 | PHASE1 | PBGENE-HBV |
The modified process hepatitis B vaccine is used for the prevention of hepatitis B virus infection and hepatitis B. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 3 clinical development as an investigational vaccine.
The modified process hepatitis B vaccine targets the hepatitis B virus. It is designed to elicit an immune response against the virus to prevent hepatitis B infection. The vaccine is being studied in healthy volunteers and in patients with hepatitis B virus infection.
The modified process hepatitis B vaccine is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The vaccine is currently in Phase 3 clinical trials for the prevention of hepatitis B.
The modified process hepatitis B vaccine is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Three Phase 3 trials have been completed, with a total enrollment of 1,682 participants.
The modified process hepatitis B vaccine has been studied in three completed Phase 3 trials: NCT00393523, a booster study in healthy volunteers aged 4 years and older; NCT00440297, a study in predialysis and dialysis patients aged 18 years and older; and NCT01251276, a challenge dose study in healthy adults aged 50 years and older.
The modified process hepatitis B vaccine is a distinct vaccine being developed by Merck & Company, Inc. It is not identified as being the same as other marketed hepatitis B vaccines. The vaccine is being evaluated in clinical trials for its safety and immunogenicity in different populations.