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CompletedNCT04893616Updated Jul 25, 2022

Cameroon HepB Birth Dose Feasibility Pilot

An interventional study of Integration of vaccination services into delivery services in Hepatitis B, sponsored by Clinton Health Access Initiative Inc.. Completed at 13 sites in Cameroon. Per ClinicalTrials.gov, last updated 2022-07-25.

Sponsored by Clinton Health Access Initiative Inc. · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Sex
All
01

Study summary

This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon.

Read the detailed description

In the Cameroon Expanded Program on Immunization (EPI), the birth dose vaccine for oral polio vaccine (OPV-0) and tuberculosis vaccine (BCG), are recommended with a third birth dose vaccine for hepatitis B (HepB-BD) being considered for introduction.

Although Cameroon introduced the HepB antigen as part of the Pentavalent vaccine into the immunization program in 2005, infants are currently unprotected until the first Penta shot at six weeks. Introduction of HepB-BD is a key priority for the Cameroon government through the National Cancer Strategy document as well as the Hepatitis Prevention and Treatment Guidelines. However, the timeliness of administration of Hepatitis B vaccine within 24 hours of birth is critical to ensure the highest efficacy and prevent transmission of the virus.

While coverage rates for BCG and OPV 0 are relatively high (91% and 78% respectively), these vaccines are often administered weeks or months after birth , not within the 24-hour timeframe recommended for Hepatitis B birth dose. Therefore, there are concerns from the Cameroon National Immunization Technical Advisory Group (NITAG) and other stakeholders on the feasibility of achieving high timely coverage of HepB-BD. The timeliness of administration of the birth dose vaccines within facilities relies on many system components including integrated processes between maternity and immunization units and healthcare worker awareness of birth dose administration guidelines.

The main aim of this pilot study is to assess the feasibility of immunizing newborns with BCG and OPV0 (and eventually HepB-BD) within 24 hours of birth by integrating routine immunization into maternity and immediate newborn care in 15 facilities in Cameroon.

Further, the specific objectives of this pilot study are to:

  1. Integrate birth dose immunizations into maternity and immediate newborn care services
  2. Measure the change in proportion of newborn receiving birth doses BCG and OPV0 within 24 hours compared to baseline data
  3. Measure the change in average age of babies receiving birth doses of BCG and OPV0
  4. Assess the operational feasibility and acceptability of interventions and describe any factors (barriers and enablers) that may influence further implementation of birth dose strategies

This feasibility assessment is to provide quantitative findings of an intervention integrating immunizations into maternity and newborn care across 15 health facilities in Cameroon. Overall, in 20 weeks an intervention phase will be followed by a final assessment. The approach will utilize quantitative data from healthcare worker surveys, the birth registry and immunization registry, and maternity unit reporting forms. The study findings will be used to inform strategy on HepB-BD introduction in Cameroon as well as interventions to strengthen service delivery structures for newborns.

02

Conditions studied

  • Hepatitis B

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03

In context

Hepatitis B

1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

This study's enrollment of 13 is below the median of 147 across 756 interventional studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Clinton Health Access Initiative Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Facilities will be those that have both an immunization unit as well as a maternity ward

Exclusion criteria

Exclusion Criteria:

  • Facilities without both units
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Intervention Arm

    These facilities will be those selected to have the intervention carried out.

    Other: Integration of vaccination services into delivery services

Interventions

  • OtherIntegration of vaccination services into delivery services

    The purpose of the work is to integrate readily available birth dose vaccinations (Oral Polio and the Tuberculosis vaccine) currently given in a separate clinic into the maternity delivery services through improved training, checklist, and job aides.

06

What researchers measure

Primary outcomes

  1. Timeliness of birth dose vaccine administration

    Median hours between birth and administration of oral polio and/or the BCG vaccine

    Time frame: 20 weeks

Secondary outcomes

  1. Coverage of birth dose vaccines

    The proportion of children born in the facility that obtain an oral polio and/or BCV vaccine

    Time frame: 20 weeks

07

Study locations

13 sites
  • CMA Dibi
    Dibi, Adamawa, Cameroon
  • CMA Mbe
    Mbe, Adamawe, Cameroon
  • HD Biyem-Assi
    Biyem Assi, Center, Cameroon
  • HD Cite Verte
    Cite Verte, Center, Cameroon
  • CMMR Etoudi
    Djoungolo, Center, Cameroon
  • CMA Ahala
    Efoulan, Center, Cameroon
  • CSIU Mbalmayo II
    Mbalmayo, Center, Cameroon
  • CSC Nkoabang
    Mfou, Center, Cameroon
  • Hospital Nicolas Barre
    Nkolndongo, Center, Cameroon
  • HD Obala
    Obala, Center, Cameroon
  • CSC Baham
    Baham, West, Cameroon
  • HD Foumbot
    Foumbot, West, Cameroon
  • HD Mifi
    Mifi, West, Cameroon
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Data on individual participant data will not be shared with other researchers. All reports will have data aggregated to the facility level. No personal identifiers will be gathered.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04893616
Lead sponsor
Clinton Health Access Initiative Inc.
Collaborators
Cameroon Expanded Program on Immunization, Bill and Melinda Gates Foundation
Responsible party
Sponsor
First posted
May 19, 2021
Start date
Jun 10, 2021
Primary completion
Dec 11, 2021
Completion
Dec 31, 2021
Last update
Jul 25, 2022

Study contacts

Ankouane Andoulo Firmin
principal investigator · Faculty of Medicine and Bio-Medical Sciences, University of Yaoundé

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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