Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

NCT02663700 | Completed Phase 1 FDA Drug

• 1 other identifier: 15-0001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a phase 1, randomized, double-blind, placebo-controlled, dose escalation trial of Sanaria's irradiated sporozoite vaccine (PfSPZ vaccine). The primary objective of this protocol is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The study duration shall be 34 months and subject participation duration shall be 15-26 months.

Conditions

Plasmodium Falciparum Infection

Keywords

Adults; Burkina Faso; malaria; PfSPZ Vaccine; Placebo; Randomized

Outcome Measures

Primary Outcomes (7)

• Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination

  Day 1 through Day 28

• Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination

  Day 57 through Day 83

• Occurrence of serious adverse events (SAEs) at any point during the study period

  Day 1 through Day 645

• Occurrence of serious adverse events (SAEs) considered related to vaccination

  Day 1 through Day 28

• Occurrence of serious adverse events (SAEs) considered related to vaccination

  Day 57 through Day 83

• Occurrence of solicited reactions

  Day 1 through Day 8

• Occurrence of solicited reactions

  Day 57 through Day 64

Secondary Outcomes (1)

• Antibody titers against P. falciparum circumsporozoite protein (CSP) at serology time points

  Day 1 through Day 127

Study Arms (5)

1.8x10^6 sporozoites 2 doses

EXPERIMENTAL

To be completed after safety data from Cohorts 1 and 2 are reviewed. Vaccination with 1.8x10\^6 sporozoites on study weeks 3 and 11. n=8

Biological: PfSPZ Vaccine

2.7x10^6 sporozoites 2 doses

EXPERIMENTAL

To be completed after safety data from Cohort 3 is reviewed. Vaccination with 1.8x10\^6 sporozoites on study weeks 5 and 13. n=8

Biological: PfSPZ Vaccine

2.7x10^6 sporozoites 3 doses

EXPERIMENTAL

Subjects to be assigned 1:1 to either PfSPZ vaccine (pending safety data from cohort 4) or placebo. Subjects will be administered the intervention on a 0, 8, and 16 week schedule (study days 1, 57, and 113). n=80

Drug: Artesunate; Biological: PfSPZ Vaccine; Other: Placebo

4.5x10^5 sporozoites 2 doses

EXPERIMENTAL

Initial vaccination arm. Vaccination with 4.5x10\^5 sporozoites on study weeks 1 and 9. n=8

Biological: PfSPZ Vaccine

9x10^5 sporozoites 2 doses

EXPERIMENTAL

Initial vaccination arm. Vaccination with 9x10\^5 sporozoites on study weeks 1 and 9. n=8

Biological: PfSPZ Vaccine

Interventions

Artesunate DRUG

Four tablets of 50mg each, totaling 200mg will be given in a single calendar day

2.7x10^6 sporozoites 3 doses

PfSPZ Vaccine BIOLOGICAL

PfSPZ is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.

1.8x10^6 sporozoites 2 doses; 2.7x10^6 sporozoites 2 doses; 2.7x10^6 sporozoites 3 doses; 4.5x10^5 sporozoites 2 doses; 9x10^5 sporozoites 2 doses

Placebo OTHER

Placebo

2.7x10^6 sporozoites 3 doses

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A male or non-pregnant female aged 21-40 years inclusive at the time of screening.
• For women, willingness not to become pregnant until 1 month after the last vaccination\*.
• \*Pre-menopausal female participants will be referred to the local family planning clinic, which offers several means of contraception that are approved and recommended by the Burkina Faso Ministry of Health. Contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) should be started 30 days before the first vaccination and continue until 30 days after last vaccination.
• Written informed consent obtained from the participant before screening.
• Available and willing to participate in follow-up for the duration of study.
• Residing in Sapone region and environs.
• Appear to be in generally good health based on clinical and laboratory investigation.

You may not qualify if:

• 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 immunosuppressants 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.
• Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study vaccination with the exception of tetanus toxoid.
• Confirmed or suspected immunosuppressive or immunodeficient condition.
• Confirmed or suspected autoimmune disease.
• History of allergic reactions or anaphylaxis to artesunate and artemisinin derivatives, vaccinations or to any vaccine component.
• History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care.
• History of allergy to any component of the vaccine formulation, including 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.
• Confirmed or suspected pregnancy or current breastfeeding.
• Laboratory evidence of liver disease (ALT \> / = 1.25 x upper limit of normal).
• Laboratory evidence of renal disease (serum or plasma creatinine \> upper limit of normal).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Centre National de Recherche et de Formation sur le Paludisme - Research and Training

Ouagadougou, Kadiogo, Burkina Faso

Location

Related Publications (2)

• Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Malar J. 2023 Dec 19;22(1):383. doi: 10.1186/s12936-023-04802-0.

  PMID: 38115002 DERIVED

• Potter GE, Callier V, Shrestha B, Joshi S, Dwivedi A, Silva JC, Laurens MB, Follmann DA, Deye GA. Can incorporating genotyping data into efficacy estimators improve efficiency of early phase malaria vaccine trials? Res Sq [Preprint]. 2023 Sep 22:rs.3.rs-3370731. doi: 10.21203/rs.3.rs-3370731/v1.

  PMID: 37790581 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Artesunate

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Sesquiterpenes; Terpenes; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 26, 2016
• Study Start: April 7, 2016
• Primary Completion: December 17, 2018
• Study Completion: December 17, 2018
• Last Updated: July 29, 2019

Record last verified: 2019-07-12

Locations

BU (1)