Impact of Vaccination of Pregnant Women with Inactivated Vaccines on Maternal and Newborn Health and Immune Responses: A Comparative Prospective Cohort Study (PregVax)

Funders
Chinese Center for Disease Control and Prevention (grant number B9R05110)

Principal Investigator
Dr. Anuraj Shankar

Location
West Nusa Tenggara Province, Indonesia

Duration
2020 – 2023

The PregVax study seeks to understand how different Covid-19 vaccines affect the health of pregnant women and their newborns, focusing on side effects, breakthrough infections, birth weight, preterm births, and immune responses.

BACKGROUND

Covid-19 infection during pregnancy can lead to more problems for both mothers and their babies. Therefore, it is recommended worldwide that pregnant women get vaccinated against Covid-19. While many pregnant women have received the vaccination, we are still unsure how the  vaccines affect the health of mothers and newborns, especially in countries with fewer resources like Indonesia.

To learn more about this, we conducted a longitudinal cohort study on pregnant women as well as their newborns in Indonesia, building on our previous studies, COVNEO and COVPREG. The women involved in the study received either inactivated vaccines, mRNA or vector-based vaccines, or no vaccine at all.

METHOD

This study is made up of two cohorts. The first group is pregnant women seeking routine antenatal care, delivery, and postnatal care. This includes women receiving two doses of CoronaVac starting in the second trimester, with the option to start in the first trimester (6,000 women). Another subset within this group receives a third booster dose between 28-36 weeks of pregnancy (3,000 women). Additionally, there is a cohort of non-pregnant women matched for age, number of children, height, and location (1,000 women).

The second group consists of 6,000 newborns from the vaccinated pregnant women groups to assess their immunity at 6 months. We use PCR tests and sequencing on nasal swabs to identify genetic variants of the virus. Information on vaccine side effects is routinely collected through WhatsApp or phone calls. We assess serum neutralizing antibodies using cPASS and isotype profiles, and measure CD4 and CD8 cell responses using ELISpot or whole blood cultures. These assessments are done using stored serum and mononuclear cells from before and after vaccination, as well as from the newborns.

AIMS

We aimed to identify side effects, breakthrough infections, and how the vaccines affect birth weight, preterm births, and immune responses.

PROGRESS TO DATE

The study, which concluded in 2023, involved around 10,000 pregnant women from West Nusa Tenggara Province, Indonesia. Research findings will be published soon.

LEARN MORE

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