Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib

Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A With Alhydrogel® Or GLA-SE As Adjuvant: A Staggered, Antigen And Adjuvant Dose-Finding, Randomized, Multi-Centre Phase Ia/Ib Trial

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01949909

Acronym

P27A

Enrollment

Registered

2013-09-25

Start date

2014-03-31

Completion date

2015-07-31

Last updated

2018-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Keywords

plasmodium falciparum, long synthetic peptide, antibody, T cell, cytokine, vaccine, safety, phase 1

Brief summary

P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase Ib).

Interventions

BIOLOGICALCH-Alum50

intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)

BIOLOGICALCH-GLA2.5/50

intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

BIOLOGICALTZ Ver

intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections

BIOLOGICALTZ Alum 50

intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)

BIOLOGICALTZ GLA 2.5/10

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)

BIOLOGICALTZ GLA5/50

intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)

BIOLOGICALTZ GLA2.5/50

intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Phase Ia Inclusion criteria: 1. Healthy volunteers aged 18-45 years 2. General good health based on history and clinical examination 3. Written informed consent obtained before any study procedure 4. Female volunteers practicing contraception before and up to 13 weeks after the last immunisation 5. Available to participate in follow-up for the duration of study (34 weeks) 6. Reachable by phone during the whole study period * Phase Ib inclusion criteria 1. Healthy male volunteers aged 18-45 years 2. General good health based on history and clinical examination 3. Written informed consent obtained before any study procedure 4. Available to participate in follow-up for the duration of study (34 weeks) 5. Reachable by phone during the whole study period 6. Having always lived in an area of low malaria transmission

Exclusion criteria

* Phase Ia

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite	15 months	The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination

Secondary

Measure	Time frame	Description
Assessment of the humoral immune response to the vaccine antigen	15 months	The humoral response to the vaccine antigen will be assessed in all volunteers by ELISA to measure the level of total antigen specific IgG.
Assessment of the cellular immune response to the vaccine antigen	15 months	The cellular immune response will be assessed in all volunteers by measuring the T cell proliferation and cytokine production following in vitro stimulation with the vaccine antigen (by Luminex on cell culture supernatant after in vitro stimulation of PBMC for 6 days with the P27A peptide). Proliferation of carboxyfluorescein diacetate succinimidyl ester (CFSE) loaded CD3+ CD4+ and CD3+CD8+ T cells will be assayed by using polychromatic flow cytometry.

Other

Measure	Time frame	Description
Exploratory outcome measure: humoral response	15 months	The humoral immune response quality will be assessed by measuring P27A specific antibodies IgG1, IgG2, IgG3, IgG4 subclasses by ELISA on samples obtained in all volunteers at day 0, week 8, week 12, week 26 and week 34.
Exploratory outcome measure: cytokine production (ICS)	15 months	The cellular immune response quality in all volunteers will be assessed by intracellular cytokine staining (ICS) for cytokines IL-2, TNF α, IFN γ and IL-10 in proliferating Carboxyfluorescein diacetate succinimidyl ester (CFSE) loaded CD3, CD4, and CD8 cells at day 0 and week 12 and 26.
Exploratory outcome measure : antibody dependent cell cytotoxicity (ADCI)	15 months	The functional humoral immune response will by ADCI in the GLA-SE and the Alhydrogel® group with the highest response, at day 0 and at an optimal time-point post vaccination.

Countries

Switzerland, Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026