Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03420053
• Date of registration: 13/12/2017
• Prospective Registration: Yes
• Primary sponsor: Sanaria Inc.
• Public title: Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults
• Scientific title: Clinical Trial to Evaluate the Safety, Immunogenicity and Efficacy of Direct Venous Inoculation of Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in HIV Negative and HIV Positive Tanzanian Adults
• Date of first enrolment: February 7, 2018
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03420053
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Tanzania

Contacts

• Name: Said Jongo, MD, MMED
• Affiliation: Ifakara Health Institute

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female adults, from 18 to 45 years of age

- Long term (at least two years) or permanent residence in the Bagamoyo district or
nearby districts in Coastal and Dar-es-Salaam regions

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

- Ability and willingness to complete the study visit schedule for safety follow-up and
protocol compliance

- Agreement to provide personal contact information and contact information of a third
party household member or close friend to study team

- Agreement not to participate in any other clinical study involving investigational
medicinal products during the study period, except enrollment in observational studies
(such a co-enrollment must be approved by the PI)

- Agreement to release medical and other information concerning contra-indications for
participation in the study, and to be attended by a study clinician for physical
examination and clinical investigations including electrocardiogram (ECG)

- Willingness to undergo all blood, urine and stool tests (as specified in the protocol)
and additional tests that may be ordered by the study clinician to rule-out
significant abnormality(ies)

- Female volunteers must be willing to take measures not to become pregnant if selected
for participation in the trial and to undergo serum pregnancy test at screening and at
defined time-points during the trial

- Volunteers for enrollment into HIV positive sub-groups must have:

1. Documented HIV infection, be in general good health and on stable ART use for at
least three (3) months, preferably six (6), prior to screening

2. WHO clinical stage 1 of HIV disease

3. CD4+ T-cell count >500 cells/µL at screening

4. Attending a care and treatment centre (CTC) within the study area for medical
management of HIV infection, and agreeing to maintain regular attendance to such
care and treatment centre while participating in the study

5. Agreement to allow the clinical team to contact and coordinate care with the
volunteer's HIV CTC.

- Correctly answering 10 out of 10 questions during informed consent process to
demonstrate the understanding of study design, study procedures, risks and benefits

- Signing and dating written informed consent, in accordance with local practice.

Exclusion Criteria:

- Previous receipt of an investigational malaria vaccine or drug in the last 5 years

- Receipt of standard vaccinations within 4 weeks prior to the first immunization with a
PfSPZ product or are planning to take standard vaccinations during the trial through 4
weeks following the last injection with a PfSPZ product

- Participation in any other clinical trial involving investigational medicinal products
within 30 days prior to the onset of the study

- Clinically significant cardiac abnormalities as indicated by history, physical
examination or clinically significant abnormalities in electrocardiogram (ECG)

- Positive family history in a 1st or 2nd degree relative for cardiac disease at age< 50
years old

- A history of psychiatric disease

- History of afebrile seizures, atypical febrile seizures or epilepsy

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

- History of chronic immunodeficiency condition (other than HIV) or autoimmune disease

- The use of chronic immunosuppressive drugs, antibiotics, or other immune modifying
drugs within three months prior to study onset (ART and inhaled and topical
corticosteroids are allowed)

- Meeting exclusion criteria based on the protocol algorithm for assessment of TB
disease risk

- Currently on Co-Trimoxazole (trimethoprim/sulfamethoxazole) prophylactic treatment
(CPT)

- Currently taking rifampin (isoniazid is not an exclusion criterion)

- Body mass index (BMI) of <18 or >30 Kg/m2

- Females who are pregnant (as indicated by positive serum pregnancy test), nursing, or
plan on becoming pregnant or nurse within the duration of trial

- Newly diagnosed with positive HIV infection at screening

- Positive hepatitis (B or C virus) tests

- Symptoms, physical signs and laboratory values suggestive of clinically significant
systemic disorders or any other conditions which could interfere with the
interpretation of the study results or compromise the health of the volunteers

- Medical, social condition or occupational reason that, in the judgment of the
investigator, is a contraindication to protocol participation, may impair the
volunteer's ability to give informed consent or effectively participate in the study,
may significantly increase the risk to the volunteer because of participation in the
study or may impair interpretation of the study data.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Malaria,Falciparum

Malaria

Intervention(s)

Biological: PfSPZ Vaccine

Biological: PfSPZ Challenge

Other: Normal Saline Placebo

Primary Outcome(s)

Safety of PfSPZ Vaccine - laboratory abnormalities [Time Frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).]

Safety of PfSPZ Vaccine - serious adverse events [Time Frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).]

Safety of PfSPZ Vaccine - unsolicited symptoms [Time Frame: From day of vaccination to 28-days post vaccination.]

Safety of PfSPZ Vaccine - solicited symptoms [Time Frame: From day of vaccination to 7-days post vaccination.]

Safety of PfSPZ Vaccine - breakthrough infection [Time Frame: Day of immunization to approximately 11 weeks after the last vaccination (approximately 36 weeks).]

Secondary ID(s)

BSPZV3a

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ifakara Health Institute

Medical Care Development, Inc.

Swiss Tropical & Public Health Institute