Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 11 April 2016
• Main ID: NCT02418962
• Date of registration: 09/04/2015
• Prospective Registration: No
• Primary sponsor: Sanaria Inc.
• Public title: Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated PfSPZ Vaccine in Equatoguinean Adults
• Scientific title: Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults
• Date of first enrolment: March 2015
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02418962
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Equatorial Guinea

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy literate male aged between 18 - 35 years

- Good health status based on history and clinical examination.

- Long term (at least two year) or permanent residence in the city of Baney or
community of Rebola, Bioko Island, Equatorial Guinea

- Free from malaria parasitaemia by blood smear at screening

- Not suffering from any chronic illness including HIV/AIDS.

- Able and willing to come for complete one year follow up.

- Answered correctly 10 out 10 questions demonstrating their understanding of study and
study procedures.

- Written informed consent.

- Volunteer agrees to inform study doctor and agrees to release medical information
concerning contra-indications for participation in the study.

- Living with a third party who will contact the study team, if there is any alteration
of consciousness during the first six months of the study.

- Willingness to be attended by a study clinician and take all necessary medications
prescribed during study period.

- Availability through mobile phone 24 hours during the whole study period.

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

- Agreement not to donate blood during the study period.

- Willingness to attend all study visits.

- Willingness to undergo HIV, hepatitis B and hepatitis C tests.

Exclusion Criteria:

- Plans to travel outside the Bioko, Equatorial Guinea in first nine months of the
study.

- Previous receipt of an investigational malaria vaccine or participation in a malaria
drug study.

- History of arrhythmias or prolonged QT-interval or other cardiac disease.

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

- A history of psychiatric disease.

- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying
drugs within three months of study onset (inhaled and topical corticosteroids are
allowed) and during the study period.

- Symptoms, physical signs and laboratory values suggestive of systemic disorders
including renal, hepatic, blood, cardiovascular, pulmonary, skin, immunodeficiency,
psychiatric, and other conditions which could interfere with the interpretation of
the study results or compromise the health of the volunteers.

- History of diabetes mellitus or cancer.

- An estimated, ten year risk of fatal cardiovascular disease of =5%, as estimated by
the Systematic Coronary Risk Evaluation (SCORE) system.

- Clinically significant abnormalities in electrocardiogram (ECG) at screening.

- 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 the onset of the
study or during the study period.

- Volunteers unable to be closely followed for social, geographic or psychological
reasons.

- Study team employees and their immediate family relatives.

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

- Risk factor for clinically active tuberculosis + positive tuberculin skin test (TST)



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

Health Condition(s) or Problem(s) studied

Malaria

Plasmodium Falciparum

Intervention(s)

Biological: PfSPZ Vaccine

Other: Normal Saline

Primary Outcome(s)

Number of adverse events as a measure of safety and tolerability [Time Frame: Until 28 days after each vaccination]

Number of Pf infections [Time Frame: From first vaccination upto 50 weeks]

Number of serious adverse events [Time Frame: From first vaccination upto 50 weeks]

Secondary Outcome(s)

Antibody titers to whole Pf sporozoite by Immunofluorescence (IFA) [Time Frame: Before each vaccination, 2 and 4 weeks after each vaccination, and at 8, and 24 weeks after the last vaccination.]

Cellular immune responses [Time Frame: Screening and at 2 and 24 weeks after the last vaccination]

Antibody titers to PfCSP, PfLSA-1, PfEXP-1 and PfMSP-5 by ELISA [Time Frame: Before each vaccination, at 2 and 4 weeks after 1st and 2nd vaccinations (groups 2 and 3) and at 2, 4, 8, and 24 weeks after the last vaccination.]

Secondary ID(s)

EGSPZV1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Marathon Oil Corporation

Noble Oil Services

Ifakara Health Institute

Government of Equatorial Guinea

Hospital Universitario La Paz

Swiss Tropical & Public Health Institute