Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
- Summary
- The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.
- Short title
- Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
- Official title
- Safety, Tolerability, Immunogenicity and Protective Efficacy Against Naturally-Transmitted Malaria in Eastern Indonesia of Two Plasmodium Falciparum Sporozoite Vaccines, Sanaria® PfSPZ Vaccine and Sanaria® PfSPZ-CVac: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial in Healthy Indonesian Adults
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2024-02-27
- First posted
- 2018-04-19
- Registry last updated
- 2026-05-04
- Primary completion date
- 2024-02-27
- Start date
- 2022-05-07
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanaria Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT03503058
- ClinicalTrials.gov ID
- NCT03503058
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
Timeframe: PfSPZ Vaccine: 7 days after each vaccination (2 days for local solicited AEs); PfSPZ-CVac: 14 days after each administration; SAEs for both products: from day of immunization until end of study (20 months-immunizations started ~2 months after FSFV).
1. The proportion of participants experiencing solicited AEs occurring within 7 days (PfSPZ Vaccine) or 14 days (PfSPZ-CVac) of each administration of investigational product (IP). 2. The proportion of participants experiencing serious adverse events (SAEs) deemed related to IP during active participation in the trial. 3. The proportion of participants experiencing unsolicited AEs occurring within 14 days of each administration of IP deemed related to vaccination or placebo administration.
Primary Efficacy Endpoint - Number of Participants With First Clinical Pf Malaria Cases
Timeframe: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).
The deployment surveillance period was from 10 days after arriving in Papua to 2 days before departure (which was the last day that the clinical team had access to the study population). Primary endpoint: number of first clinical malaria cases caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Clinical malaria caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test) plus * measured axillary temperature ≥ 37.5 degrees Celsius or history of fever in the last 24 hours; or * at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; or * meeting criteria for severe malaria (this third option was not used).
Secondary Efficacy Endpoint - Number of Confirmed First Infections Caused by Pf
Timeframe: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).
The deployment surveillance period extended from 10 days after arriving in Papua to two days before departure (which was the last day that the clinical team had access to the study population). Secondary endpoint: number of first infections caused by Pf among participants receiving vaccine (either vaccine group) vs. placebo (both placebo groups combined) during: * the first 24 weeks of deployment * the entire period of deployment (293 days, or approximately 42 weeks). Malaria infection caused by Pf was defined as a positive thick blood smear (TBS) at any density (or PCR confirmed rapid diagnostic test).
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- A male aged 18-55 years at the time of screening.
- Assigned to the battalion of study and programmed to accompany it to eastern Indonesia for the duration of the deployment.
- Freely provides written informed consent to participate in the study.
- Agrees to adhere to Indonesian military medical guidance regarding screening and treatment of malaria.
- Physical examination and laboratory results without clinically significant findings that would jeopardize the safety of the participant or the integrity of the study, and a body mass index (BMI) ≤35 kg/m^2.
- Previous vaccination with an investigational malaria vaccine.
- Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months before the first vaccination. This includes any dose level of oral steroids, but not inhaled steroids or topical steroids.
- Administration or planned administration of 1 live or 3 or more other type vaccines in the period beginning 28 days before the first study vaccination and ending 28 days after the last vaccination.
- Confirmed or suspected immunosuppressive or immunodeficient condition.
- Confirmed or suspected autoimmune disease.
- History of allergic reactions or anaphylaxis to CQ or other 4-aminoquinolone derivatives.
- History of serious allergic reactions to a drug (anaphylaxis, or requiring hospitalization).
- History of allergy to phosphate buffered saline or human serum albumin.
- Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians.
- History of splenectomy.
- Laboratory evidence of liver disease (the final decision will be made by the PI and clinical officers, but in general a volunteer will be excluded if any of the screening liver function tests (ALT, bilirubin, gamma GTP) are > double the upper limit of normal measured twice without an explanation for the abnormal values).
- Laboratory evidence of renal disease (serum creatinine > 1.5 mg/dL. measured twice).
- Laboratory evidence of hematologic disease (platelet count or hemoglobin <80% of the lower limit of normal for Indonesia measured twice).
- Abnormal screening ECG showing prolonged QTc interval (>450 msec) or any signs of arrythmia/irregularity, ischemia, cardiac enlargement considered considered indicative of acute or chronic cardiovascular disease.
- Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that may increase the risk of participating in the study as determined by the principal investigator or her designee.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period.
- Simultaneous participation in any other interventional clinical trial.
- Other conditions that in the opinion of the principal investigator or her designee would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol or might compromise the integrity of the data.
- Any evidence of active malaria, whether symptomatic or asymptomatic, confirmed by RDT, microscopy or PCR before first injection of PfSPZ Vaccine or PfSPZ-CVac, unless treated by the clinical team.
- History of non-febrile seizures or atypical febrile seizures.
- Under treatment for tuberculosis.
- Laboratory evidence of active infection with hepatitis B, or hepatitis C.
- Subjects with > 10% 5-year cardiovascular risk (fatal and non-fatal) based on the Gaziano scoring system; subjects in the 18-34 year old age group will be assessed as though they are in the 35-44 age group.
- History of psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult.
- Department of Internal Medicine, Universitas IndonesiaJakarta, Indonesia
- Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular BiologyJakarta, Indonesia
Related records
Drugs (1)
Collaborators (3)
- Congressionally Directed Medical Research Programs
- Indonesia University
- Oxford University Clinical Research Unit Indonesia
Lead sponsors (1)
Conditions (2)
- Malaria Primary condition
- Plasmodium falciparum malaria