NCT02015091

Study of Controlled Human Malaria Infections to Evaluate Protection After Intravenous or Intramuscular Administration of PfSPZ Vaccine in Malaria-Naive Adults

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing PfSPZ Vaccine in Malaria in 141 participants. Completed in 8 September 2016.

Timeline

12 December 2013

Primary endpoint
1 May 2015

8 September 2016

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	141
Start date	12 December 2013
Primary completion	1 May 2015
Estimated completion	8 September 2016
Sites	2 locations across United States

Drugs / interventions tested

• PfSPZ Vaccine — full drug profile →

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 45, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- People bitten by mosquitoes carrying weakened malaria parasites could fight off the disease if later exposed to normal malaria parasites. Scientists have discovered how to make the weakened parasites, which can be injected by the PfSPZ vaccine. Researchers want to see if people who receive the vaccine get malaria after being bitten in a controlled setting (a controlled human malaria infection, CHMI).

Objective:

\- To see if the PfSPZ malaria vaccine is safe and prevents malaria in a controlled setting.

Eligibility:

\- Healthy adults 18 45 years old.

Design:

* Participants will be screened with medical history, physical exam, blood and lab tests, and EKG.
* Participants will be split into 8 groups, to be in the study for 3 12 months.
* Participants will receive 3 5 vaccinations, injected by a needle in an arm vein or muscle.
* Participants will keep a health diary and be contacted by phone.
* For CHMI, a cup with mosquitoes carrying malaria is applied to participants arm for 5 minutes. Five mosquitoes at a time are used, until 5 have bitten. Some groups will be exposed to malaria more than once.
* After CHMI, participants will visit the clinic very frequently (including daily visits for 12 days) for 28 days.
* Blood will be drawn at most visits, from 1 to 20 tubes. Physical exam and medical history may also be repeated
* Participants who develop malaria will be treated immediately at the clinic. Standard treatment takes 72 hours. Malaria symptoms may last up to 3 days.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Protection against malaria at 1 year and immune correlates following PfSPZ vaccination.
   Ishizuka AS, Lyke KE, DeZure A, Berry AA, et al · · 2016 · cited 299× · PMID 27158907 · DOI 10.1038/nm.4110
2. A human monoclonal antibody prevents malaria infection by targeting a new site of vulnerability on the parasite.
   Kisalu NK, Idris AH, Weidle C, Flores-Garcia Y, et al · · 2018 · cited 250× · PMID 29554083 · DOI 10.1038/nm.4512
3. Attenuated PfSPZ Vaccine induces strain-transcending T cells and durable protection against heterologous controlled human malaria infection.
   Lyke KE, Ishizuka AS, Berry AA, Chakravarty S, et al · · 2017 · cited 188× · PMID 28223498 · DOI 10.1073/pnas.1615324114
4. Atypical B cells are part of an alternative lineage of B cells that participates in responses to vaccination and infection in humans.
   Sutton HJ, Aye R, Idris AH, Vistein R, et al · · 2021 · cited 180× · PMID 33567273 · DOI 10.1016/j.celrep.2020.108684
5. A Potent Anti-Malarial Human Monoclonal Antibody Targets Circumsporozoite Protein Minor Repeats and Neutralizes Sporozoites in the Liver.
   Wang LT, Pereira LS, Flores-Garcia Y, O'Connor J, et al · · 2020 · cited 136× · PMID 32946741 · DOI 10.1016/j.immuni.2020.08.014
6. Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines.
   Richie TL, Billingsley PF, Sim BK, James ER, et al · · 2015 · cited 133× · PMID 26469720 · DOI 10.1016/j.vaccine.2015.09.096
7. The march toward malaria vaccines.
   Hoffman SL, Vekemans J, Richie TL, Duffy PE. · · 2015 · cited 91× · PMID 26324116 · DOI 10.1016/j.vaccine.2015.07.091
8. The March Toward Malaria Vaccines.
   Hoffman SL, Vekemans J, Richie TL, Duffy PE. · · 2015 · cited 68× · PMID 26590432 · DOI 10.1016/j.amepre.2015.09.011