Pan-Malaria Transmission-Blocking Vaccine AnAPN1

NCT05905432 | Completed Phase 1 DMC

• 1 other identifier: AnAPN1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Malaria is still responsible for more than 627,000 deaths each year, predominantly among children under 5 years old. Current reductions in deaths have stagnated, and additional setbacks for malaria control programs due to the Coronavirus Disease 2019 (COVID-19) pandemic are expected. To achieve malaria elimination and eradication a leverage concerted approaches to reduce clinical disease and prevent new infections is a must. The existing malaria controls tools including the a recombinant protein-based malaria vaccine (RTS,S ,(trade name MosquirixMosquirix )), a malaria vaccine currently undergoing implementation studies and endorsed by the World Health Organization on October 7, 2021, can reduce disease burden for patients but cannot ultimately support malaria elimination and eradication since their effect on malaria transmission is at most partial. Consequently, complementary interventions, such as transmission-blocking vaccines (TBVs) may prove to be a cost-effective intervention that can reduce on-going residual transmission and the cascade of new infections.

Conditions

Malaria

Keywords

transmission blocking

Outcome Measures

Primary Outcomes (1)

• Adverse events related to the vaccination.

  Number and grade of adverse events possibly, likely, and definitely related to vaccination.

  Day 14

Secondary Outcomes (1)

• anti-UF6b IgG concentration

  Day 28

Study Arms (3)

Dosage A1

EXPERIMENTAL

n=2 will receive a dose of 20 mcg UF6b (A1), n=9 will receive 20 mcg AnAPN1: GLA-LSQ (5 mcg GLA/2 mcg LSQ) (A2)

Drug: Vaccine AnAPN1

Dosage B1

EXPERIMENTAL

n=2 will receive 50 mcg UF6b (B1), n=9 will receive 50 mcg UF6b: GLA- LSQ (12.5 mcg GLA/5 mcg LSQ) (B2)

Drug: Vaccine AnAPN1

Dosage C1

EXPERIMENTAL

n=2 will receive 100 mcg UF6b (C1); n=9 will receive 100 mcg UF6b: GLA- LSQ (25 mcg GLA/10 mcg LSQ) (C2)

Drug: Vaccine AnAPN1

Interventions

Vaccine AnAPN1 DRUG

AnAPN1 is a recombinant protein expressed in Escherichia coli. It consists of the UF6b construct, derived from the sequence of the Anopheles gambiae alanyl aminopeptidase N (XM\_318000.4) and will be formulated with or without Synthetic Glucopyranosyl Lipid A (GLA)- LSQ adjuvant. Route of administration is intramuscular.

Dosage A1; Dosage B1; Dosage C1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female volunteers aged 18-45 years.
• Able and willing (in the investigator's opinion) to comply with all trial requirements.
• General good health based on medical history and clinical examination.
• Written informed consent.
• Available to participate in follow up for the duration of trial (6 months following the last injection).
• Reachable by phone during the whole trial period.
• Women only: Must agree to practice continuous effective contraception for the duration of the trial.

You may not qualify if:

• Positive for P. falciparum sexual and asexual stages by thick blood smear microscopy on admission and documented parasitologically confirmed malaria parasites of at least 1000 parasite/microliter in the past four weeks.
• Pregnancy, lactation, or intention to become pregnant during the trial.
• Previous participation in a malaria vaccine trial.
• HIV and microscopically detectable schistosomiasis and Soil-Transmitted helminth infection.

Sponsors & Collaborators

• Centre de Recherche Médicale de Lambaréné: lead
• Global Health Innovative Technology Fund: collaborator

Study Sites (1)

Centre de Recherches Médicales de Lammbaréné

Lambaréné, Moyen-Ogooué Province, 1437, Gabon

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ayôla Akim ADEGNIKA

  Centre de Recherches Medicales de Lambarene

  PRINCIPAL INVESTIGATOR

• Rhoel DINGLASAN

  University of Florida

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: June 15, 2023
• Study Start: September 11, 2023
• Primary Completion: January 22, 2025
• Study Completion: January 31, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GA (1)