MedTrace Logo

Study of the Safety and Immunogenicity of Pfs230D1M-EPA/Alhydrogel and Pfs25M-EPA/Alhydrogel , a Transmission Blocking Vaccine Against Plasmodium Falciparum Malaria, in Adults in the U.S. and Mali

NCT02334462 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 538

Last updated 2019-04-11

No results posted yet for this study

Summary

Background:

\- Malaria is a severe infection caused by a parasite. People can get malaria if a mosquito that carries the parasite bites them. Malaria infection does not happen in the United States, but many people in Africa, Asia, and South America are at risk for it. Researchers want to test two vaccines that may help decrease malaria infection.

Objective:

\- To see if two vaccines (Pfs25M-EPA/Alhydrogel and Pfs230DIM-EPA/Alhydrogel ) are safe in humans and cause an immune response that will prevent malaria parasites from correctly growing in the mosquito.

Eligibility:

\- Healthy adults ages 18 50.

Design:

* There are several groups in this study. Each group will receive a different dose of the vaccine and some groups will received both vaccines.
* Vaccinations will be given on two days about 4 weeks apart.
* Participants will receive each vaccine as an injection into the arm. Blood will be drawn on the day of vaccination.
* In the 4 weeks after receiving a vaccination, participants will have at least 3 clinic visits and 1 phone contact. They will have at least 3 more visits and 3 phone contacts over the next 6 months.
* At each visit, participants will be evaluated for side effects to the vaccine and any new health changes or problems. They will be asked how they are feeling and if they have taken any medicine. Blood and urine samples may be taken at the visit. More follow-up visits may be needed to follow up on changes or problems.

Conditions

Interventions

BIOLOGICAL

Pfs230D1M-EPA/Alhydrogel

BIOLOGICAL

Pfs25M-EPA/Alhydrogel

DRUG

TWINRIX

DRUG

Menactra

Sponsors & Collaborators

  • Rodolphe Merieux Laboratory@@@Bamako, Mali

    collaborator UNKNOWN

  • 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
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-07
Primary Completion
2016-03-31
Completion
2018-10-22
FDA Drug
Yes

Countries

  • United States
  • 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 NCT02334462 on ClinicalTrials.gov