Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897946
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : September 26, 2019
Sponsor:
Collaborators:
The American Society of Tropical Medicine and Hygiene
Burroughs Wellcome
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:
This project will assess the immunogenicity of a birth dose of hepatitis B vaccine in hepatitis B-exposed and hepatitis B-unexposed infants in Kinshasa, Democratic Republic of the Congo. A better understanding of the protection offered by the addition of birth dose vaccine to the EPI schedule is necessary in order to promote universal adoption of a birth dose vaccine in the DRC and throughout SSA.

Condition or disease Intervention/treatment Phase
Hepatitis B Biological: Birth dose hepatitis B vaccine Phase 4

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: The participants and care providers will not be masked, but the investigators and data analysts will be masked to group allocation.
Primary Purpose: Prevention
Official Title: Evaluating Immunogenicity of a Birth Dose of HBV Vaccine in the DRC
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Hepatitis B exposed, with birth dose
The 100 HBV-exposed (born to HBsAg-positive mothers) infants who are already enrolled in the parent AVERT study will also be enrolled in the current study, as the "HBV-exposed cohort" (Group A). These exposed infants will not receive additional interventions on top of the AVERT study since they will already be receiving a birth dose vaccine through the AVERT study.
Biological: Birth dose hepatitis B vaccine
Groups A and C will receive a birth dose of hepatitis B vaccine within 24 hours of life.

No Intervention: Group B: Hepatitis B unexposed, no birth dose
For the "HBV-unexposed cohort" in this study, the investigators will enroll 200 infants born to HBsAg-negative mothers. Half (100) of these infants will receive the routine three-dose series of HBV vaccine according to the standard EPI schedule in the DRC with no additional birth dose vaccine (Group B).
Experimental: Group C: Hepatitis B unexposed, with birth dose
Group C will consist of the other half (100) of infants in the "HBV-unexposed cohort" who will receive four doses of HBV vaccine including a birth dose vaccine prior to the routine EPI schedule.
Biological: Birth dose hepatitis B vaccine
Groups A and C will receive a birth dose of hepatitis B vaccine within 24 hours of life.




Primary Outcome Measures :
  1. Proportion of Infants with Protective Immunity [ Time Frame: At 12 months of age ]
    Protective immunity is defined as quantitative HBsAb ≥ 10 milli-International unit(mIU)/mL


Secondary Outcome Measures :
  1. Proportion of Infants with Adverse Reactions to the Birth Dose Hepatitis B Vaccine [ Time Frame: Within 2-3 days after birth ]
    Adverse reactions will include fever, fatigue and injection site soreness, as described in the Package Insert (https://www.fda.gov/downloads/biologicsbloodvaccines/vaccines/approvedproducts/ucm224503.pdf). Infants will be monitored for adverse reactions for safety purposes during the time they spend with their mothers at the maternity center after birth (expected average stay of 2-3 days).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

MOTHERS

Inclusion Criteria

  • HBsAg+ mothers and HBsAg- mothers will be recruited from the cohort screened during the AVERT study at 2 maternity centers (Binza and Kingasani) in Kinshasa.

Exclusion Criteria

  • Any women who do not intend to stay in Kinshasa for prenatal care through delivery or who deliver at a facility other than Binza or Kingasani
  • Women <18 years of age

INFANTS

Inclusion Criteria

  • Infants born to HBsAg-positive and HBsAg-negative women who receive care at Binza and Kingasani maternity centers will be recruited for participation in this study.

Exclusion Criteria

  • HIV-exposed infants (those born to HIV-positive mothers) will be excluded given an expected difference in immune response in these infants and inability to recruit enough HIV-exposed infants to be able to detect these differences in immune response
  • HBV-unexposed infants weighing <2,000 grams at birth will not be eligible to receive the birth HBV vaccine. (HBV-exposed infants receive the birth dose vaccine regardless of birth weight because the potential benefit of preventing mother-to-child transmission outweighs the potential risk of vaccination in a low birthweight infant. The research team recognizes that Group B may include a disproportionate number of low birthweight infants compared to Group C, but will account for this in post-hoc analyses and if need be, will exclude low birthweight infants from the analysis to account for potential bias).
  • Infants born at a facility other than one of the two maternity centers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897946


Contacts
Layout table for location contacts
Contact: Peyton Thompson, MD 919-445-0854 peyton_thompson@med.unc.edu

Locations
Layout table for location information
Congo, The Democratic Republic of the
Binza and Kingasani Maternity Centers Recruiting
Kinshasa, Congo, The Democratic Republic of the
Contact: Patrick Ngimbi       patrickngimbi1@gmail.com   
Contact: Kashamuka Mwandagalirwa       mkashamuka@yahoo.com   
Sponsors and Collaborators
University of North Carolina, Chapel Hill
The American Society of Tropical Medicine and Hygiene
Burroughs Wellcome
Investigators
Layout table for investigator information
Study Director: Steven R Meshnick, MD, PhD UNC-Chapel Hill
Principal Investigator: Peyton J Thompson, MD UNC-Chapel Hill

Additional Information:
Publications:

Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03897946     History of Changes
Other Study ID Numbers: 18-2793
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Vaccines
Immunologic Factors
Physiological Effects of Drugs