Phase 2
N=1,301
Pfs230D1M-EPA/AS01 Vaccine, a Transmission Blocking Vaccine Against Plasmodium Falciparum, in an Age De-Escalation Trial of Children and a Family Compound Trial in Mali
Malaria
Bottom Line
View on ClinicalTrials.gov: NCT03917654 ↗Enrolled (actual)
1,301
Serious AEs
1.1%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants With Local and Systemic Adverse Events in Years 1 and 2 — 15; 14; 15; 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Pfs230D1M-EPA/AS01 (Biological); HAVRIX (Biological); TYPHIM Vi (Salmonella typhi vaccine) (Biological); Menactra (Biological); AVAXIM (Biological)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Local and Systemic Adverse Events in Years 1 and 2 |
15; 14; 15; 15; 96; 85 | — |
Summary
Background:
Malaria affects many people in Mali and other parts of Africa. It is spread by mosquito bites. Malaria can make people sick or can lead to death. Scientists want to learn if a vaccine can stop it from spreading to other people.
Objective:
To test how well an experimental malaria vaccine works to decrease malaria infections.
Eligibility:
Healthy people ages 5 and older who live in Doneguebougou, Mali, and surrounding areas
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
EKG
Participants will be randomly assigned to get either the experimental vaccine or an approved vaccine. They will not know which they are getting.
Participants will have a visit about a week before their first vaccine. They will take a medicine that kills malaria. They will take it at the clinic the next 2 days. Participants ages 5-8 will take the drug again 2 weeks before their third vaccine.
Participants get the vaccine through a needle in the arm. They will have visits 1, 3, 7, and 14 days after. They will have blood tests or finger pricks.
Participants will get another vaccine 1 and 6 months later.
Participants will have blood tests once a month. At these visits they may also have urines tests or mosquito feeds. For the feeds a cup full of mosquitoes will be placed on arms or legs for 15-20 minutes.
Participants will have visits twice a month for 4 months after their last vaccine.
Eligibility Criteria
- INCLUSION CRITERIA FOR GROUPS 1,2,3:
All of the following criteria must be fulfilled for a volunteer to participate in this trial:
- Meets age requirements for Arm currently being enrolled.
- Available for the duration of the trial.
- Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 0 and until 1 month after the last vaccination.
- A reliable method of birth control includes one of the following:
- Confirmed pharmacologic contraceptives (parenteral) delivery;
- Intrauterine or implantable device
EXCEPTIONS to required pregnancy prevention includes the following:
- Postmenopausal state: defined as no menses for 12 months without an alternative medical cause
- Surgical sterilization
- Unmarried AND not sexually active AND menstruating OR not menstruating females 12-17 years of age
- NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become >=18 years of age, married, or sexually active), the female will be required to start reliable contraception
- Willing to have blood samples stored for future research.
INCLUSION CRITERIA FOR GROUP 4:
All of the following criteria must be fulfilled for a volunteer to participate in this trial:
- Meets age requirements for Arm currently being enrolled.
- Available for the duration of the trial.
- Family compound known resident or long-term resident (more than 1 year) of Doneguebougou, Mali or surrounding villages.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Willing to have blood samples stored for future research.
Inclusion Criteria for Groups 1, 2, 3, (Year 2)
All of the following criteria must be fulfilled for a volunteer to continue to participate in this trial:
- Previously enrolled in the study and has received at least 1 vaccination. 2. Available for the duration of the trial.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Females of childbearing potential must be willing to use reliable contraception from 21 days prior to scheduled vaccine dose #4 and until 1 month after the 4th vaccination.
-A reliable method of birth control includes one of the following:
- Confirmed pharmacologic contraceptives (parenteral) delivery;
- Intrauterine or implantable device
EXCEPTIONS to required pregnancy prevention includes the following:
- Postmenopausal state: defined as no menses for 12 months without an alternative medical cause
- Surgical sterilization
- Unmarried AND not sexually active AND menstruatingOR not menstruating females 12-17 years of age
- NOTE: if a female of childbearing potential s status changes during the course of vaccination through 1 month post vaccination (e.g. they become greater than or equal to 18 years of age, married, or sexually active), the female will be required to start reliable contraception
- Willing to have blood samples stored for future research.
Inclusion Criteria for Group 4 (Year 2):
All of the following criteria must be fulfilled for a volunteer to continue to participate in this trial:
- Previously enrolled in the study
- Available for the duration of the trial.
- In good general health and without clinically significant medical history in the opinion of the investigator.
- Willing to have blood samples stored for future research.
EXCLUSION CRITERIA FOR GROUPS 1, 2
Data sourced from ClinicalTrials.gov (NCT03917654). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.