NCT00424944

A Single Centre, Randomised Controlled Trial to Evaluate the Safety and Immunogenicity of Recombinant Lactococcus Lactis Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine Versus Rabies Vaccine in Healthy Gabonese Adult Volunteers

Status unknown Phase 1 Last updated 1 April 2008

What this trial tests

Phase 1 trial testing GMZ2 (malaria vaccine) in Malaria in 40 participants. Status unknown.

Timeline

1 June 2007

Primary endpoint
1 July 2008

1 August 2008

Quick facts

Lead sponsor	African Malaria Network Trust
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	prevention
Enrollment	40
Start date	1 June 2007
Primary completion	1 July 2008
Estimated completion	1 August 2008
Sites	1 location across Gabon

Drugs / interventions tested

• GMZ2 (malaria vaccine) — full drug profile →
• GMZ2 malaria vaccine
• Verorab vaccine — full drug profile →

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

African Malaria Network Trust

Who can join

Adults 18 to 45, male only, with Malaria. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Local and systemic reactogenicity
  Time frame: 28 days following each immunization
• Unsolicited adverse events
  Time frame: 1 year
• Occurrence of serious adverse events
  Time frame: 1 year
• Biological safety
  Time frame: 1 year

Sponsor's own description

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters.

This is the first time this product will be tested in Africa

Publications & conference data

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

1. Safety and immunogenicity of the malaria vaccine candidate GMZ2 in malaria-exposed, adult individuals from Lambaréné, Gabon.
   Mordmüller B, Szywon K, Greutelaers B, Esen M, et al · · 2010 · cited 53× · PMID 20696154 · DOI 10.1016/j.vaccine.2010.07.085
2. Blood stage vaccines for Plasmodium falciparum: current status and the way forward.
   Ellis RD, Sagara I, Doumbo O, Wu Y. · · 2010 · cited 45× · PMID 20519960 · DOI 10.4161/hv.6.8.11446
3. <i>Plasmodium falciparum</i> Malaria Vaccines and Vaccine Adjuvants.
   Bonam SR, Rénia L, Tadepalli G, Bayry J, et al · · 2021 · cited 29× · PMID 34696180 · DOI 10.3390/vaccines9101072
4. Host-parasite interactions during <i>Plasmodium</i> infection: Implications for immunotherapies.
   Chandley P, Ranjan R, Kumar S, Rohatgi S. · · 2022 · cited 18× · PMID 36685595 · DOI 10.3389/fimmu.2022.1091961
5. Malaria therapeutics: are we close enough?
   Tripathi H, Bhalerao P, Singh S, Arya H, et al · · 2023 · cited 12× · PMID 37060004 · DOI 10.1186/s13071-023-05755-8
6. Preliminary evaluation of the safety and efficacy of oral human antimicrobial peptide LL-37 in the treatment of patients of COVID-19, a small-scale, single-arm, exploratory safety study
   Zhang H, Zhao Y, Jiang X, Zhao Y, et al · · 2020 · cited 2× · DOI 10.1101/2020.05.11.20064584
7. Approaching the target: the path towards an effective malaria vaccine.
   García-Basteiro AL, Bassat Q, Alonso PL. · · 2012 · cited 1× · PMID 22550560 · DOI 10.4084/mjhid.2012.015