Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)

ISRCTN	ISRCTN28820504
DOI	https://doi.org/10.1186/ISRCTN28820504
Protocol serial number	WHO/RPC041
Sponsor	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)
Funder	World Health Organization (WHO)/Department of Immunisation, Vaccines and Biologicals (IVB) (Switzerland)

Submission date: 04/08/2004
Registration date: 22/09/2004
Last edited: 10/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Tracey Goodman
Scientific

World Health Organization
20, Avenue Appia
Geneva-27
CH-1211
Switzerland

Email	goodmant@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Assessment of serological responses to Hepatitis B and Hib vaccines in infants receiving vitamin A (Ghana)
Study objectives	Hypothesis: The simultaneous administration of vitamin A with the pentavalent vaccine may reduce or enhance the serological response to Hepatitis B and Haemophilus influenzae type b vaccines in infants. Aim: To evaluate the seroconversion rates of administering the pentavalent vaccine with vitamin A supplements using two different supplementation regimes. That is: 1. Supplementation of mothers with 400,000 IU vitamin A at 6 weeks in two divided doses and supplementation of children with 50,000 IU vitamin A at 6,10 and 14 weeks 2. Supplementation of mothers alone with 400,000 IU vitamin A at 6 weeks in two divided doses Specific objectives: 1. To measure the antibody response to Hepatitis B vaccination and Haemophilus influenza type b vaccination in infants given 50,000 IU of vitamin A at 6,10 and 14 weeks and whose mothers were given 400,000 IU of vitamin A at 6 weeks post partum 2. To measure the antibody response to Hepatitis B vaccination and Haemophilus influenza type b vaccination in infants whose mothers only were given 400,000 IU of vitamin A at 6 weeks post partum 3. To assess the impact of vitamin A given to infants at the time of vaccination (6, 10, and 14 weeks) on the seroconversion rates of Hepatitis B and Haemophilus influenza b vaccines
Ethics approval(s)	Ethics approval received from the World Health Organization (WHO) Secretariat Committee on Research Involving Human Subjects (SCRIHS) - conditional approval received on 12th December 2003, amendments approved on 6th April 2007.
Health condition(s) or problem(s) studied	Immunology/vaccines
Intervention	Treatment group: 1. Mothers at 6 weeks: 200,000 IU Vitamin A x 2 (day 1 and day 2) 2. Infants at 6, 10 and 14 weeks: 50,000 IU Vitamin A and Diphtheria, Pertussis, Tetanus (DPT), Hepatitis B (HepB) and Haemophilus influenzae type b (Hib) vaccines Control group: 1. Mothers 200,000 IU Vitamin A x 2 (day 1 and day 2) 2. Infants: DPT, HepB and Hib alone
Intervention type	Supplement
Primary outcome measure(s)	The impact of the different doses of vitamin A on the pentavalent vaccines will be assessed by comparing the two groups in terms of their seroconversion rates for: 1. Hepatitis B 2. Haemophilus influenzae type b The choice of four months for reevaluation is because this is the age at which it is presently recommended to determine the seroconversion rates. Accordingly, pre-samples will be taken at 6 weeks prior to DPT-HepB Hib immunisation and post samples will be taken at 1 month after the DPT-HepB Hib immunisation.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1042
Total final enrolment	1077
Key inclusion criteria	1. Live-born infants 2. Willingness of mothers to participate in the study 3. Must reside in the study area for at least 4 months after the birth 4. Consent to two blood samples before and after their child's vaccination
Key exclusion criteria	Does not comply with above inclusion criteria
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

Ghana
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		01/05/2007		Yes	No

Editorial Notes

10/11/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.