Safety and Immunogenicity Study of Influenza Vaccines in HIV-infected and HIV-uninfected Pregnant Women in Western Kenya

Summary

In 2012, the WHO Strategic Advisory Group of Experts (SAGE) concluded that pregnant women are the most important risk group for season influenza vaccination based upon "compelling evidence of substantial risk of severe disease in this group and evidence that seasonal influenza vaccine is safe and effective in preventing disease in pregnant women as well as their young infants, in whom disease burden is also high". Recent data from Kenya, similarly suggest rates of influenza-associated hospitalizations in children under age 1 to be as high, or higher, than those observed in the United States. However, TIV may have reduced immunogenicity in HIV-infected adults, and HIV infection has been shown to reduce placental transfer of both tetanus and measles antibodies. Therefore, we propose to conduct a double-blind randomized controlled trial of influenza vaccines stratified by HIV status in up to 720 pregnant women in their second and third trimesters and their infants residing in health and demographic surveillance sites (HDSS) in Nyanza Province, Western Kenya. We propose to assess the safety, immunogenicity, and efficacy of standard dose QIV and double dose QIV in HIV-infected and HIV-uninfected pregnant women. Findings will inform maternal influenza vaccination policies in Kenya and other African countries.

Conditions

• Influenza, Human
• HIV
• Malaria
• Tetanus
• Polio

Interventions

BIOLOGICAL

Quadrivalent Inactivated Influenza Vaccine (QIV)

BIOLOGICAL

Inactivated Polio Vaccine

BIOLOGICAL

Double Dose QIV

Sponsors & Collaborators

• Centers for Disease Control and Prevention

  lead FED

Principal Investigators

• Meredith L McMorrow, MD, MPH · Centers for Disease Control and Prevention

• Joshua A Mott, PhD · Centers for Disease Control and Prevention Kenya Country Office

• Nancy Otieno, MS · Kenya Medical Research Institute

• Marc-Alain Widdowson, VetMB, MSc · Centers for Disease Control and Prevention

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

13 Years

Max Age

49 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-04-30

Primary Completion

2014-04-30

Completion

2014-04-30

Countries

• Kenya

Study Locations