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Safety, Immunogenicity, and Protective Efficacy of Two Regimens of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Natural Transmission Season in Healthy African Adults in Mali

NCT03510481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2021-08-20

Study results available
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Summary

Background:

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.

Objective:

To study how safe and tolerable the malaria vaccine called PfSPZ Vaccine is for healthy adults.

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 prior to 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 prior to the third injection and prior to fourth injection.

They will be followed for approximately 6 months after third and fourth injection.

At vaccine visits, female participants will have a pregnancy test before injection. All participants will have an 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.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

PfSPZ Vaccine is Radiation attenuated, aseptic, purified, vialed, cryopreserved, NF54 P. falciparum sporozoites produced by Sanaria, Inc.

DRUG

Normal Saline

Clear liquid indistinguishable from the study product will be used as a placebo rather than a comparator vaccine.

DRUG

artemether 20mg/lumefantrine 120mg (AL)

Licensed antimalarial in the US and Mali for use for uncomplicated malaria.

Sponsors & Collaborators

  • Sanaria Inc.

    collaborator INDUSTRY

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Patrick E Duffy, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2019-11-23
Completion
2020-02-13
FDA Drug
Yes

Countries

  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510481 on ClinicalTrials.gov