A phase I randomised single-blinded single-centre study comparing doses of Plasmodium falciparum chimeric protein 2.9 (PfCP-2.9) recombinant vaccine adjuvanted with Montanide ISA 720 for safety and immunogenicity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66850051

Enrollment

Registered

2007-10-01

Start date

2003-08-11

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Malaria Infections and Infestations Malaria

Interventions

1. Intervention dose group: 20 micrograms PfCP2.9/Montanide ISA 720

administered intramuscularly on Day 0, Day 60 and Day 180 2. Intervention dose group: 50 micrograms PfCP2.9/Montanide ISA 720

administered intramuscularly on Day 0, Day 60 and Day 180 3. Intervention dose group: 100 micrograms PfCP2.9/Montanide ISA 720

administered intramuscularly on Day 0, Day 60 and Day 180 4. Intervention dose group: 200 micrograms PfCP2.9/Montanide ISA 720

administered intramuscularly on Day 0, Day 60 and Day 180 5. Placebo control group: Montanide ISA 720

administered intramuscularly on Day 0, Day 60 and Day 180 Contact information for Principal Investigator: Dr Jinhong Hu Clinical Center of Pharmacology Changhai Hospital Second Military Medical Univ

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Healthy adult volunteers ages 18 - 45 years.

Exclusion criteria

Exclusion criteria: 1. History of malaria: persons infected with malaria or with positive markers for antibodies to malaria parasite by Indirect Fluorescent Antibody (IFA) assay 2. History of ever traveling to or residing in a malaria endemic region or malaria exposure within last two years

Design outcomes

Primary

Measure	Time frame
1. Local and systemic tolerability 2. Reported adverse events	—

Secondary

Measure	Time frame
1. Antibody titres by Enzyme-Linked Immuno-Sorbent Assay (ELISA) 2. Antibody titres by IFA Test (IFAT) 3. Lymphocyte stimulation indices	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 5, 2026