Two regimens of PfSPZ Vaccine during natural transmission season in healthy African adults in Mali

The disease malaria affects many people in Mali and other parts of Africa and the world. It is caused by germs spread by mosquito bites. Malaria may be mild. But it can also be serious or lead to death if it is not treated promptly. Researchers want to find a safe vaccine that prevents malaria.
Eligibility:
Healthy adults: ages 18-35 in Ouelessebougou, Mali, not infected with HIV, hepatitis B, or hepatitis C for females, not pregnant or breastfeeding, and must use reliable birth control during the study
Design:
Participants will be screened with questions about malaria and will undergo blood, urine, and heart tests.
Participants will be randomly assigned to 1 of 4 groups. They will get injections of either the PfSPZ Vaccine or a salt-water placebo. They will not know which one they get.
Vaccinations will occur leading into the malaria transmission each year with 3 injections leading into Year 1 (malaria transmission season in 2018) and 1 injection before Year 2 (malaria transmission season 2019).
One vaccine group and one placebo group will get an injection 3 times over 4 weeks with an additional vaccination ~10 months later.
The other two groups (vaccine group and placebo) will get an injection 3 times over 16 weeks with an additional vaccination ~10 months later.
All participants will be treated with an antimalarial medication before the third injection and before fourth injection.
They will be followed for approximately 6 months after the third and fourth injections.
At vaccine visits, female participants will have a pregnancy test before injection. All participants will have their arm cleaned and the vaccine injected in a vein. They will be watched for 30 minutes.
At non-vaccine visits, participants will have a physical exam and be asked how they are feeling. They will usually have blood tests.

Study type: Interventional
Enrollment: 478 participant
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking: Double (Participant, Investigator)
NCT number: NCT03510481
Phase: Phase I

Clinical trial registrationProject details

Vaccines

May 2018 — Feb 2020

$410,498

Mali