Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02132299
• Date of registration: 29/04/2014
• Prospective Registration: No
• Primary sponsor: Sanaria Inc.
• Public title: Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
• Scientific title: Phase 1, Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults
• Date of first enrolment: April 2014
• Target sample size: 67
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02132299
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Tanzania

Contacts

• Name: Salim Abdulla, MD, PhD
• Affiliation: Ifakara Health Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male aged between 18 - 35 years.

- Good health status based on history and clinical examination.

- Long term or permanent resident in or near Dar-es-Salaam.

- Able and willing to complete the study visit schedule over the one year follow up
period, including the hospitalizations required for protocol compliance.

- Able and willing to complete the informed consent process conducted in English.

- Demonstrate understanding of the study and procedures by answering 20 questions from
the Protocol & Study Procedures Understanding Checklist correctly with a maximum of
two attempts.

- Agrees to inform study doctor of medical conditions and contraindications for
participation in the study.

- Agrees to provide contact information to the study team for a household member who
will serve as an emergency contact during trial participation.

- Willing to be attended by a study doctor and take medications, which may be
prescribed by a study doctor, during study participation.

- Reachable (24/7) by mobile phone during the whole study period.

- Agrees not to participate in another study during the study period.

- Agrees not to donate blood during the study period.

- Willing to undergo HIV, hepatitis B and hepatitis C testing.

- Willing to undergo controlled human malaria infection (CHMI).

Exclusion Criteria:

- History of malaria in the past 5 years.

- Positive for malaria by thick blood smear at screening.

- Plans to travel outside the Dar-es-Salaam or Coast Region in first 12 months of the
study.

- Previous receipt of an investigational malaria vaccine.

- Antibodies to parasites or selected parasite protein(s) above acceptable cut off
established for the site

- History of arrhythmias or prolonged QT-interval or other cardiac disease or
clinically significant abnormalities in electrocardiogram (ECG) at screening.

- History or indication of a history of drug or alcohol abuse interfering with normal
social function.

- Use of chronic immunosuppressive drugs, antibiotics, or other immune modifying drugs
within three months of study enrollment (inhaled and topical corticosteroids are
allowed).

- Ongoing condition that could interfere with the interpretation of the study results
or compromise the health of the volunteer.

- History of diabetes mellitus or cancer.

- Body Mass Index (BMI) below 18 or above 30 kg/m2.

- Any clinically significant deviation from the normal range in biochemistry or
hematology blood tests or in urine analysis or electrolytes.

- Positive HIV, Hepatitis B virus or Hepatitis C virus tests.

- Participation in any other clinical study within 30 days prior to study enrollment.

- Known hypersensitivity, allergy, or other contra-indications to Coartem® or Malarone®
including treatment taken by the volunteer that interferes with Coartem® or
Malarone®.

- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
asplenia.

- Heterozygous or homozygous for sickle cell or homozygous for alpha thalassemia.

- Glucose-6-phosphate dehydrogenase deficiency

- Psychiatric condition that precludes compliance with the protocol; past or present
psychoses; disorder requiring lithium; or within five years prior to enrollment,
history of suicide plan or attempt.

- Any medical, psychiatric, social condition, or occupational reason that, in the
judgment of the investigator, is a contraindication to protocol participation or
impairs the volunteer's ability to give informed consent, increases the risk to the
volunteer because of participation in the study, affect the ability of the volunteer
to participate in the study or impair interpretation of the study data.

- History of 3 or more other immunizations within the six months before administration
of the first dose of vaccine.

- Clinically active tuberculosis



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Plasmodium Falciparum Malaria

Malaria

Intervention(s)

Biological: PfSPZ Vaccine

Biological: PfSPZ Challenge

Biological: Normal Saline (Placebo)

Primary Outcome(s)

Protective Efficacy after CHMI with PfSPZ Challenge (NF54) - CHMI Endpoints [Time Frame: CHMI to 28 days after CHMI]

Safety and tolerability endpoints [Time Frame: Vaccination to CHMI (or 28 days after last vaccination); CHMI to 28 days after CHMI]

Secondary Outcome(s)

Immune Responses after PfSPZ Vaccine [Time Frame: 16 months]

Protective effect of the high dose PfSPZ Vaccine regimen [Time Frame: CHMI to day 28 after CHMI]

Secondary ID(s)

BSPZV1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ifakara Health Institute

Tanzania Commission for Science and Technology

Swiss Tropical & Public Health Institute