Trial results for the VAX-MOM COVID-19 study, focused on increasing maternal COVID-19 vaccination, were posted on ClinicalTrials.gov on 2025-09-04, involving 6911 participants.
Background
COVID-19 infection during pregnancy is associated with increased risks, including pre-eclampsia, preterm birth, and stillbirth. Pregnant individuals with COVID-19 also face a higher rate of ICU admission and intubation compared to those who are not pregnant. Despite these risks and the recommendation for COVID-19 vaccination before and during pregnancy, vaccination rates have been a concern. As of June 2022, only 71% of pregnant women were vaccinated for COVID-19, with a significantly lower rate of 58% among non-Hispanic Black women. This highlights a need for effective interventions to improve COVID-19 vaccination rates in this population.
Trial design
This completed study, designated as Phase NA, enrolled 6911 participants to investigate conditions including Immunization; Infection, Pregnancy Related, and COVID-19. The trial compared a VAX-MOM COVID-19 intervention, designed to improve maternal COVID-19 vaccination rates, against a Standard of Care group.
Key results
The trial reported key measurements for COVID-19 vaccination rates at 6 and 9 months:
- Rate of COVID-19 Vaccination (6 Month):
- In the VAX-MOM COVID-19 Intervention group, 251 participants were vaccinated.
- In the Standard of Care group, 130 participants were vaccinated.
- Rate of COVID-19 Vaccination (9 Month):
- In the VAX-MOM COVID-19 Intervention group, 404 participants were vaccinated.
- In the Standard of Care group, 180 participants were vaccinated.
What this means
The results indicate that the VAX-MOM COVID-19 intervention was associated with an increase in maternal COVID-19 vaccination rates compared to standard care. At both the 6-month and 9-month follow-up points, a higher number of participants in the intervention group received vaccination. These findings suggest that targeted interventions like VAX-MOM could be effective in improving vaccination uptake among pregnant individuals, potentially mitigating the risks associated with COVID-19 during pregnancy.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05570630, titled "VAX-MOM COVID-19: Increasing Maternal COVID-19 Vaccination", were posted on 2025-09-04 on clinicaltrials.gov.