Implementing Vaccine Clinical Trial in Pregnant Women: Lessons learnt from the WoMANPOWER vaccine trial.

February 22, 2023

By Dr. Alexander Amone

Dr. Alexander Amone, Study Coordinator – WoMANPOWER

Enrolling pregnant women in vaccine clinical trials face a number of hurdles in low income countries such as Uganda. These challenges stem from lack of knowledge, negative community perception about vaccines, lack of infrastructure for vaccine clinical trials and problems with recruiting and retaining pregnant women into a vaccine clinical trial. The WoMANPOWER study is a vaccine clinical trial that was conducted among pregnant women enrolled from Kawempe National Referral Hospital and Kisenyi Health Centre IV. This study provided an opportunity for pregnant women in Uganda to take part in a clinical trial of a vaccine that is already being used in some developed countries. To our knowledge, this is the first vaccine clinical trial to be conducted among pregnant women in Kawempe National Referral Hospital and Kisenyi Health Centre IV.

Pregnant women were screened and enrolled from the Antenatal Clinics (ANC) of the respective health facility. As is the norm, enrolled participants were monitored for 30 minutes after receiving the vaccine. This required setting up a vaccination and monitoring area within the available space provided by the institution. In both Kawempe and Kisenyi, one clinic room was given for the study. This room was partitioned in to two: a vaccination section that was only accessible to vaccination nurses, and a monitoring section for the midwife and clinician to monitor participants after vaccination. This section was equipped with first aid kit, oxygen and emergency trolley.

The vaccine was prepared centrally from MU-JHU pharmacy and transported by MU-JHU courier in a cradle cube for temperature control to the respective clinics on the day of vaccination. Thereafter, the cradle cube was transported back to MU-JHU pharmacy by the courier.

Lessons learnt

We demonstrated that it is possible to carry out a vaccine clinical trial among pregnant women in Uganda. Community sensitization carried out with different stakeholders was helpful in clearing concerns and misconceptions among community leaders. Currently, the WoMANPOWER study is at the stage of data cleaning and analysis.

With strict inclusion and exclusion criteria for a vaccine trial among pregnant women, it is important to explore other hospitals and health centres where potential participants can be recruited. Working closely together with ANC providers and the neonatal and child health care providers is paramount since they are involved in the care of pregnant women and their babies. Continuous engagement with leadership of the hospitals and health centres is key in sustaining success of vaccine clinical trials moving forward.

Vaccine clinical trials among pregnant women directly strengthens maternal, neonatal and child health care within the existing government health care structure. Having trained study staff who closely follow up participants (who are hospital patients), providing clinical care and supporting with investigations and drugs that may not be available in the hospital are some of the ways that strengthen clinical care for participants. This directly benefits the hospital and the women enrolled in vaccine clinical trials. This information needs to be made available to other hospitals and health centres with potential to host vaccine clinical trials among pregnant women to expand the number of health facilities where vaccine clinical trials can be carried out among pregnant women.

With the experience that trained staff have got in implementing the WoMANPOWER study in Kawempe National Referral Hospital and Kisenyi Health centre IV, we believe that it is possible for future vaccine studies in pregnant women to be carried out successfully in Uganda. The stage has therefore been set for more vaccine clinical trials among pregnant women.



Romana Nabbosa