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Plasmodium Falciparum InfectionPhase 1NCT02663700

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

A Phase 1 study testing Artesunate and PfSPZ Vaccine in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Plasmodium Falciparum Infection
What is being tested?
Artesunate and PfSPZ Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
112 participants
Where
1 siteBurkina Faso
Study dates
7 Apr 2016to 17 Dec 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 22Show fewer
  • 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).
  • Laboratory evidence of hematologic disease (platelet count <115,000/mm^3, or hemoglobin <11.2 g/dL for males and <9.5 g/dL for females).
  • Seropositive for hepatitis B surface antigen or hepatitis C virus (hepatitis C antibody).
  • Seropositive for HIV.
  • Sickle cell trait carriage or sickle cell disease.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period. 20. Simultaneous participation in any other interventional clinical trial.
  • 21. 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 PI. 22. Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol. 23. Documented history of non-febrile seizures or atypical (complex) febrile seizures.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

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

    Ouagadougou, Kadiogo

Other trials in Burkina Faso

About this study

Official title: Dose Escalation Study of Sanaria's Irradiated Sporozoite Vaccine (PFSPZ Vaccine), Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PfSPZ Vaccine in Malaria-Experienced Adults in Burkina Faso

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.

Read the detailed description

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 study is to determine the safety and reactogenicity of the PfSPZ Vaccine in malaria-experienced healthy adults. The secondary objective is to evaluate vaccine-induced anti-CSP antibody immune responses. The study duration shall be 34 months and subject participation duration shall be 15-26 months.

Being tested
Artesunate, PfSPZ Vaccine, Placebo
Keywords
Adults, Burkina Faso, malaria, PfSPZ Vaccine, Placebo, Randomized
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ArtesunateDrug

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

  • PfSPZ VaccineBiological

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

  • PlaceboOther

    Placebo

Study groups in NCT02663700
Study groupRoleWhat they receive
1.8x10^6 sporozoites 2 dosesExperimentalTo 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
Receives: Biological: PfSPZ Vaccine
2.7x10^6 sporozoites 2 dosesExperimentalTo be completed after safety data from Cohort 3 is reviewed. Vaccination with 1.8x10^6 sporozoites on study weeks 5 and 13. n=8
Receives: Biological: PfSPZ Vaccine
2.7x10^6 sporozoites 3 dosesExperimentalSubjects 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
Receives: Drug: Artesunate; Biological: PfSPZ Vaccine; Other: Placebo
4.5x10^5 sporozoites 2 dosesExperimentalInitial vaccination arm. Vaccination with 4.5x10^5 sporozoites on study weeks 1 and 9. n=8
Receives: Biological: PfSPZ Vaccine
9x10^5 sporozoites 2 dosesExperimentalInitial vaccination arm. Vaccination with 9x10^5 sporozoites on study weeks 1 and 9. n=8
Receives: Biological: PfSPZ Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 through Day 28

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

    Measured: Day 57 through Day 83

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

    Measured: Day 1 through Day 645

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

    Measured: Day 1 through Day 28

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

    Measured: Day 57 through Day 83

  6. Occurrence of solicited reactions

    Measured: Day 1 through Day 8

  7. Occurrence of solicited reactions

    Measured: Day 57 through Day 64

Secondary outcomes (1)

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

    Measured: Day 1 through Day 127

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2016 (estimated)
  2. Study start7 Apr 2016
  3. Primary completion17 Dec 2018
  4. Study completion17 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
112 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02663700
Sponsor's protocol ID
15-0001
Status last verified
12 Jul 2019
First submitted
21 Jan 2016
Last updated
29 Jul 2019
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 38115002

  • 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.

    PubMed 37790581

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Artesunate and PfSPZ Vaccine in people with Plasmodium Falciparum Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Burkina Faso.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination (time frame: Day 1 through Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02663700, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2019.

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