Recombivax HB (hepatitis B vaccine recombinant) / Merck (MSD) - LARVOL DELTA

Hepatitis B Vaccine Compliance and Seroresponse Rates Among Solid Organ Transplant Recipients Receiving Recombinant versus Adjuvanted HBV Vaccine (WTC 2025) - "Subjects that received Engerix-B (GSK) or Recombivax-HB (Merck) were categorized as recombinant HBV vaccine, while those who received Heplisav-B (Dynavax) were categorized as adjuvanted HBV vaccine...HBV vaccine type was unknown for 23.2% (n=92), while 4.5% (n=18) received Twinrix (Hep A/B)... HBV vaccination rates remain suboptimal in SOTR. There was a trend towards higher HBV vaccine completion rates with adjuvanted HBV vaccine. While there was no difference in seroresponse between adjuvanted and recombinant HBV vaccination, seroresponse rates to adjuvanted HBV vaccine were lower in this cohort than those achieved in phase 3 clinical trials (over 90%)."

Clinical • Compliance • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

Posttransplant HBV Vaccine Compliance, Seroprotection, and Kinetics of Hepatitis B Surface Antibody in Thoracic Organ Transplant Recipients. (PubMed, Transpl Infect Dis) - "Suboptimal compliance with HBV vaccination and poor vaccine-induced seroprotection occur in thoracic organ transplant recipients, regardless of the vaccine used. These findings underscore the necessity of enhancing vaccination strategies for SOT recipients."

Compliance • Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

POST-TRANSPLANT HBV VACCINE COMPLIANCE AND SEROPROTECTION IN THORACIC ORGAN TRANSPLANT RECIPIENTS (AASLD 2024) - "However, data on post-transplant hepatitis B virus (HBV) vaccination compliance and vaccine-induced seroprotection from conventional recombinant hepatitis B vaccine (Recombivax HB) versus CpG-adjuvanted recombinant hepatitis B vaccine (Heplisav-B) are lacking. We observed suboptimal post-transplant HBV vaccine compliance and poor vaccine-induced seroprotection in thoracic organ transplant recipients, regardless of the vaccine used. This study's findings emphasize the need to explore alternative post-transplant HBV vaccination strategies to improve both compliance and seroprotection."

Clinical • Compliance • Post-transplantation • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2026 ➔ Sep 2025

Trial completion date • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Hepatitis B Vaccine Compliance, Serologic Response, and Durability in Adult Thoracic Organ Transplant Recipients. (PubMed, Clin Transplant) - "Although less than half of thoracic organ transplant candidates completed HBV vaccine series pretransplant, Heplisav-B provided a higher vaccine completion rate and seroprotection than the 3-dose Recombivax HB. Clinicians should also be aware of the increased loss of HBV seroprotection in thoracic organ transplant recipients with age ≥ 60 years and pretransplant HBsAb between 10 and 100 IU/L. Assessment of seroprotection after HBV vaccination should be prioritized during the pretransplant period."

Compliance • Journal • Retrospective data • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Hepatitis B Vaccine Compliance and Seroresponse in Adult Thoracic Organ Transplant Candidates (ATC 2024) - "Although less than half of thoracic organ transplant candidates completed HBV vaccine series pre-transplant, Heplisav-B provided a higher vaccine completion rate and seroprotection than the 3-dose Recombivax HB. Given these findings, means to improve vaccination compliance are needed and preference to the shorter administration completion of Heplisav can help, with improved seroconversion rates. Assessment of seroprotection after HBV vaccination should be prioritized during the pre-transplant period."

Clinical • Compliance • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

Rapid Serologic Response of Patients with Advanced CKD to HepB-CpG Vaccination (KIDNEY WEEK 2023) - "There are 3 recommended HBV vaccines available in the US: Recombivax-HB, Engerix-B and Heplisav-B (HepB-CpG). In our real world clinical experience, HepB-CpG produces a rapid serologic response in advanced CKD patients requiring less doses compared to the high dose of the traditional HBV vaccines (Engerix or Recombivax-HB). Ongoing immunosuppression and active malignancy were the common causes of response failure."

Clinical • Metastases • Chronic Kidney Disease • Hematological Malignancies • Hepatitis B • Hepatology • Infectious Disease • Multiple Myeloma • Nephrology • Oncology • Renal Disease • Solid Organ Transplantation • Solid Tumor • Transplantation

Impaired Seroconversion Rates After Adjuvanted Hepatitis B Vaccination in Organ Transplant Candidates and Recipients (ATC 2023) - "Purpose: Adjuvanted hepatitis B vaccine (Heplisav B by Dynavax) offers improved seroconversion rates versus non-adjuvanted hepatitis B vaccines (Engerix B by GlaxoSmithKline, Recombivax HB by Merck). This is a first report of seroconversion rates to the adjuvanted hepatitis B vaccine in an organ transplant population. Seroconversion rates of 57-82% are much lower than the 90+% seroconversion rates achieved in the Phase III trials. Alternate vaccination strategies with third doses or second series will often be warranted in an organ transplant patient population."

Clinical • Hepatitis B • Hepatology • Infectious Disease • Inflammation • Solid Organ Transplantation • Transplantation

Adult immunization. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Pneumococcal Infections • Respiratory Diseases • Tetanus • Varicella Zoster

Expanded table: Some vaccines for adults. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Herpes Zoster • Infectious Disease • Inflammation • Influenza • Meningococcal Infections • Pertussis • Respiratory Diseases • Tetanus • Varicella Zoster

A three-antigen hepatitis B vaccine (PreHevbrio). (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hepatitis B • Hepatology • Infectious Disease • Inflammation

Serological response with Heplisav-B® in prior Hepatitis B vaccine non-responders living with HIV. (PubMed, Vaccine) - "Heplisav-B® was highly effective in achieving immunity to HBV in PLWH who failed non-adjuvanted recombinant vaccines."

Journal • Hepatitis B • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • CD4

PNEU-PED: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (clinicaltrials.gov) - P3; N=1720; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease • Pneumococcal Infections

Hepatitis B Vaccination Response in Hemodialysis Patients: The Impact of Dialysis Shift. (PubMed, Blood Purif) - "While better sleep following vaccination is associated with seroconversion in the general population, this is not the case in hemodialysis patients after multivariate adjustment. In the context of end-stage kidney disease, early dialysis start is not a significant predictor of HB vaccination response. The association between objectively measured postvaccination sleep duration and seroconversion rate should be investigated."

Clinical • Journal • Chronic Kidney Disease • Hepatitis B • Hepatology • Infectious Disease • Nephrology • Renal Disease • Sleep Disorder

A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION) (clinicaltrials.gov) - P3; N=900; Completed; Sponsor: Merck Sharp & Dohme Corp.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

[VIRTUAL] Hepatitis B Virus Screening and Vaccination in Patients with HIV: A Survey of Physicians’ Current Clinical Practices (IDWeek 2020) - "Almost half of participants (43%) indicated they would use Heplisav-B over older HBV vaccine formulations (Energix-B or Recombivax-HB) for initial vaccination of susceptible patients. This study provides insight into current HBV vaccination and monitoring practices of physicians who care for patients with HIV. The results revealed varied practice preferences and opportunities for improvement through standardization. Additional research is needed to elucidate the impact these various practices have on patient outcomes and healthcare expenditure."

Clinical • Hepatitis B • Human Immunodeficiency Virus • Infectious Disease

From Infancy and Beyond… Ensuring a lifetime of hepatitis B virus (HBV) vaccine-induced immunity. (PubMed, Hum Vaccin Immunother) - "...Several universal neonatal immunization programs initially incorporated a 2.5 μg dosage (Recombivax-HB, Merck). This dosage has been shown in multiple long-term studies and meta-analyses to be associated with a lower primary response, decreased antibody persistence over time, and a reduced booster response 10 to 20 years following immunization. Ongoing surveillance of this and other HBV neonatally-vaccinated populations, particularly in low endemic regions, is necessary to understand the impact on long-term protection in order to ensure lifelong protection against hepatitis B infection."

Journal • Biosimilar • Immunology

Lot-to-Lot Consistency, Safety, Tolerability, and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. (PubMed) - Pediatr Infect Dis J - P3; "HV demonstrated lot-to-lot manufacturing consistency; safety and immunogenicity were comparable with the licensed vaccines. HV provides a new combination vaccine option within the US 2,4,6 month vaccine series."

Journal • Biosimilar

Extreme Duration of Positive Hepatitis B Surface Antigen (HBsAg) after Vaccination in a Hemodialysis Patient (KIDNEY WEEK 2017) - "The two vaccines available in the U.S., Engerix-B (ENG) and Recombivax HB (REC), are both produced by cloning HBV DNA into the yeast Saccharomyces cerevisae and harvesting and purifying the resultant HBsAg expressed by the yeast. The mechanism for this persistent Ag positivity is not clear, but was almost certainly not active HBV infection, and was temporally very closely correlated with REC vaccination. The sequential use of two different vaccines may have played a role through differences in their antigenic structure, but this is not certain. Explanation of this phenomenon will require further study, but this case illustrates the extreme variability of HBV Ag/Ab assay results after HBV vaccination in patients on hemodialysis."

Clinical • Chronic Kidney Disease • Renal Disease

DTaP5-HB-IPV-Hib Vaccine (Vaxelis(®)): A Review of its Use in Primary and Booster Vaccination. (PubMed) - Paediatr Drugs - "Primary endpoints of seroprotection or vaccine response rates with Vaxelis(®) met the predefined acceptability criteria and were noninferior to those with comparator vaccines (Infanrix(®) hexa or Pentacel(®) plus Recombivax HB(®)). In clinical studies, Vaxelis(®) was generally well tolerated with a tolerability profile similar to that of the comparator vaccines. Available clinical data indicate that Vaxelis(®) is a new hexavalent vaccine option for immunization against several serious childhood infectious diseases."

Journal • Biosimilar • Immunology

PNEU-PED: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (clinicaltrials.gov) - P3; N=1720; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; Trial primary completion date: Dec 2020 ➔ May 2021

Clinical • Trial primary completion date

PNEU-PED: Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (clinicaltrials.gov) - P3; N=1720; Active, not recruiting; Sponsor: Merck Sharp & Dohme Corp.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed