MalariaPhase 1PamTBVacNCT05905432
Pan-Malaria Transmission-Blocking Vaccine AnAPN1
A Phase 1 study testing Vaccine AnAPN1 in people with Malaria, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Vaccine AnAPN1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteGabon
- Study dates
- 11 Sep 2023to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Centre de Recherches Médicales de Lammbaréné
Lambaréné, Moyen-Ogooué Province, 1437
About this study
Official title: A Randomized Double-blinded Phase 1 Clinical Trial to Assess Safety, Tolerability and Reactogenicity of the Pan-Malaria Transmission-Blocking Vaccine AnAPN1 in Healthy Adults Living in Gabon
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.
Read the detailed description
TBVs work by blocking parasite transmission to and from mosquitoes, with the added benefit of preventing the spread of parasites that have developed drug resistance or those that are vaccine-escape mutants of e.g. RTS,S. However, blocking transmission of all malaria species will be mandatory to achieve a globally relevant impact on malaria morbidity and mortality with Plasmodium falciparum and Plasmodium vivax being the most relevant targets. To date, the mosquito recombinant protein antigen vaccine Anopheline Alanyl Aminopeptidase N (AnAPN1)is the only TBV candidate that meets this need, wherein antibodies to this vaccine block both human malaria parasite species, underscoring its potential for supporting malaria elimination. The AnAPN1 vaccine consists of the AnAPN1 dimer antigen construct (UF6b) construct derived from the sequence of a protein of the mosquito midgut (Anopheles gambiae alanyl aminopeptidase), expressed as a recombinant protein in bacteria. With Global Health Innovative Technology Fund( GHIT) (G2020-208) support, the AnAPN1 reaches the First-In-Human milestone.
- Conditions
- Malaria
- Being tested
- Vaccine AnAPN1
- Keywords
- transmission blocking
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine AnAPN1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: Drug: Vaccine AnAPN1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events related to the vaccination.
Number and grade of adverse events possibly, likely, and definitely related to vaccination.
Measured: Day 14
Secondary outcomes (1)
anti-UF6b IgG concentration
Area under the curve of anti-UF6b immunoglobulin G (IgG) concentration, using a qualified and validated ELISA protocol.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start11 Sep 2023
- Primary completion22 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Global Health Innovative Technology Fund
- Responsible party
- Principal investigator, Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné
- Investigators
- Ayôla Akim ADEGNIKA, Principal investigator, Centre de Recherches Medicales de LambareneRhoel DINGLASAN, Study director, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05905432
- Sponsor's protocol ID
- AnAPN1
- Acronym
- PamTBVac
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2023
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blinded Phase 1 Clinical Trial to Assess Safety, Tolerability and Reactogenicity of the Pan-Malaria Transmission-Blocking Vaccine AnAPN1 in Healthy Adults Living in Gabon
- ClinicalTrials.gov ID
- NCT05905432
- Acronym / sponsor ID
- PamTBVac / AnAPN1
- Conditions
- Malaria
- Keywords
- transmission blocking
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Global Health Innovative Technology Fund
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
TBVs work by blocking parasite transmission to and from mosquitoes, with the added benefit of preventing the spread of parasites that have developed drug resistance or those that are vaccine-escape mutants of e.g. RTS,S. However, blocking transmission of all malaria species will be mandatory to achieve a globally relevant impact on malaria morbidity and mortality with Plasmodium falciparum and Plasmodium vivax being the most relevant targets. To date, the mosquito recombinant protein antigen vaccine Anopheline Alanyl Aminopeptidase N (AnAPN1)is the only TBV candidate that meets this need, wherein antibodies to this vaccine block both human malaria parasite species, underscoring its potential for supporting malaria elimination. The AnAPN1 vaccine consists of the AnAPN1 dimer antigen construct (UF6b) construct derived from the sequence of a protein of the mosquito midgut (Anopheles gambiae alanyl aminopeptidase), expressed as a recombinant protein in bacteria. With Global Health Innovative Technology Fund( GHIT) (G2020-208) support, the AnAPN1 reaches the First-In-Human milestone.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dosage A1 | Experimental | Drug: Vaccine AnAPN1n=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) |
| Dosage B1 | Experimental | Drug: Vaccine AnAPN1n=2 will receive 50 mcg UF6b (B1), n=9 will receive 50 mcg UF6b: GLA- LSQ (12.5 mcg GLA/5 mcg LSQ) (B2) |
| Dosage C1 | Experimental | Drug: Vaccine AnAPN1n=2 will receive 100 mcg UF6b (C1); n=9 will receive 100 mcg UF6b: GLA- LSQ (25 mcg GLA/10 mcg LSQ) (C2) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaccine AnAPN1AnAPN1 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. | Drug | Dosage A1, Dosage B1, Dosage C1 |
Primary outcome
Adverse events related to the vaccination.
Time frame: Day 14
Number and grade of adverse events possibly, likely, and definitely related to vaccination.
1 secondary outcome
anti-UF6b IgG concentration
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayôla Akim ADEGNIKA principal investigator
Centre de Recherches Medicales de Lambarene
Rhoel DINGLASAN study director
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vaccine AnAPN1 in people with Malaria, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events related to the vaccination. (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.