Vitamin A and Maternal-infant Flu Vaccine Response

NCT00817661 | Completed DMC

• 1 other identifier: 2008-069
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza viral infection can cause serious illness among young infants 0-6 months of age. However, inactivated influenza vaccine is not recommended for this age group but pregnant women can be vaccinated during 2nd - 3rd trimester to induce passive immunization of their infants. Nevertheless vitamin A deficiency is highly prevalent among pregnant women in Bangladesh, \>50% pregnant women consume less vitamin A than the recommended level. Given the fact that both clinical and sub-clinical vitamin A deficiency impair vaccine specific immunity, in this proposed study, we aim to investigate whether maternal vitamin A supplementation improve influenza vaccine specific immune responses among pregnant women and the passive protection of their infants. In a placebo controlled clinical trial, sixty six mothers will be randomly assigned to receive either 10,000 IU vitamin A or placebo capsules weekly from second trimester to 6 month postnatal period. At 26-28 weeks of gestation, all mothers will be vaccinated with inactivated, trivalent influenza virus vaccine. Maternal and cord blood will be collected for vitamin A and influenza virus specific IgG assessment. Colostrum and breast milk at 6-month will be collected for vitamin A and influenza virus specific secretory IgA assessment. Venous blood (2-3 ml) will be obtained from all infants at the age of 6 months for vitamin A and influenza virus specific IgG assessment as well as infants' nasal swab for influenza virus specific secretory IgA.

Conditions

Influenza

Keywords

vitamin A; influenza vaccine; passive immunity; pregnant mothers; vitamin A suplementation; Influenza vaccination; Infant immune responses

Outcome Measures

Primary Outcomes (1)

• Peripheral blood serum Vitamin A Peripheral blood serum Influenza IgG Cord blood plasma Vitamin A Cord blood plasma Influenza IgG Colostrum Vitamin A Colostrum Influenza sIgA

  9 months

Secondary Outcomes (2)

• Mothers (6 mo postpartum) serum Vitamin A serum Influ IgG Breast milk Vitamin A, Influ sIgA Infants (6 mo) Anthropometry serum Vitamin A serum Influ IgG Nasal Influ sIgA

  6 months

• Mothers (6 mo postpartum) serum Vitamin A serum Influenza IgG Breast milk Vitamin A Breast milk Influenza sIgA Infants (6 mo) Anthropometry serum Vitamin A serum Influenza IgG

  6 months

Study Arms (2)

1

EXPERIMENTAL

Vitamin A group

Dietary Supplement: Vitamin A

2

PLACEBO COMPARATOR

Placebo group

Dietary Supplement: Placebo

Interventions

Vitamin A DIETARY_SUPPLEMENT

10000 IU Vitamin A or placebo per week

1

Placebo DIETARY_SUPPLEMENT

10000 IU Vitamin A or placebo per week

2

Eligibility Criteria

• Age: 22 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• mothers at the beginning of second trimester (i.e. approximately 12 weeks of gestation)
• willing to stay in Dhaka during pregnancy and willing to admit in the clinic at delivery
• the gestational age will be determined by self-reported LMP, which is likely be underestimated in most cases. A two-week variation will be acceptable in this proposed study

You may not qualify if:

• history of systemic disease
• previous complicated pregnancies or of pre-term delivery
• abortion
• congenital anomaly
• hypersensitivity to influenza vaccine or receipt of the vaccine

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Shaikh M Ahmad

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Ahmad SM, Alam MJ, Khanam A, Rashid M, Islam S, Kabir Y, Raqib R, Steinhoff MC. Vitamin A Supplementation during Pregnancy Enhances Pandemic H1N1 Vaccine Response in Mothers, but Enhancement of Transplacental Antibody Transfer May Depend on When Mothers Are Vaccinated during Pregnancy. J Nutr. 2018 Dec 1;148(12):1968-1975. doi: 10.1093/jn/nxy228.

  PMID: 30517724 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Shaikh M Ahmad, Ph.D.

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2009
• First Posted: January 6, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: January 3, 2013

Record last verified: 2009-01

Locations

BA (1)