At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 50 years
- ✓Good general health without clinically significant medical history
- ✓Willing to undergo controlled human malaria infection (CHMI) and comply with post-CHMI follow-up (except Group 4B)
- ✓Agrees to refrain from blood donation to blood banks for 3 years following CHMI (except Group 4B)
- ✕Previous receipt of any malaria vaccine
- ✕History of malaria infection
- ✕History of severe SARS-CoV-2 infection or active SARS-CoV-2 infection
- ✕Active SARS-CoV-2 infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Dose Escalation, Open-Label Clinical Trial With Experimental Controlled Human Malaria Infections (CHMI) to Evaluate Safety and Protective Efficacy of an Anti-Malaria Human Monoclonal Antibody, VRC-MALMAB0100-00-AB (CIS43LS), in Healthy, Malaria-Naive Adults
In Brief
A Phase 1 clinical trial evaluating VRC-MALMAB0100-00-AB and Plasmodium falciparum (P. falciparum) sporozoite challenge for Malaria. Completed, enrolled 71 participants across 2 sites.
Detailed Summary
Background: People get malaria when they are bitten by an infected mosquito. Malaria can be serious and sometimes deadly. Although there are medicines to treat malaria, there is no vaccine that fully prevents infection. Researchers want to test if an experimental drug can help. Objective: To test the safety and effectiveness of a drug called CIS43LS that could prevent malaria infection. Eligibility: Healthy people ages 18-50 who have never been infected with malaria Design: Participants were enrolled on the basis of eligibility criteria, evaluated by clinical laboratory tests, self-reported medical history, and physical examination. Participants received CIS43LS either infused into a vein in their arm or injected into the fat under the skin. They were monitored for side effects for up to 4 hours after they received the drug. Participants received a thermometer and recorded their temperature and symptoms every day on/with/via a diary card for 7 days after administration. The administration site was checked for redness, swelling, itching or bruising. Participants had up to 12 follow-up visits. At follow-up visits, participants had blood drawn and were checked for health changes or problems. Most participants who received CIS43LS took part in a Controlled Human Malaria Infection Challenge (CHMI) along with control participants who did not receive CIS43LS. During the CHMI, mosquitoes carrying the malaria parasite bit participants in a controlled setting. The participants had clinic visits every day for up to 12 days starting 7 days after the CHMI. Participants were treated right away with antimalarial medication if they tested positive for malaria. Approximately 21 days after the CHMI, participants were treated with antimalarial medication for 3 days. The study lasted 2-6 months depending on the participant's study group.
Study Details
Timeline
Interventions
VRC-MALMAB0100-00-AB (CIS43LS) is a monoclonal antibody that recognizes a unique and conserved region of the Plasmodium falciparum (P. falciparum) circumsporozoite protein and incorporates an LS mutation to increase product half-life in plasma.
Participants were exposed to bites on the forearm from Anopheles stephensi mosquitoes infected with P. falciparum (3D7 strain).