Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00295581
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-02-23
Brief Title:
PpPfs25ISA51 and ScPvs25ISA51 Vaccines for Malaria
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase 1 Study of the Safety and Immunogenicity of PpPfs25ISA51 and ScPvs25ISA51 Transmission Blocking Vaccines for Plasmodium Falciparum and Plasmodium Vivax Malaria
Status:
COMPLETED
Status Verified Date:
2008-06-17
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted at Johns Hopkins University Center for Immunization Research in Washington DC will test the safety and immune response of healthy volunteers to two experimental malaria vaccines Malaria is a disease of red blood cells caused by a parasite that spreads from person to person by mosquitoes It affects people of all ages but is particularly severe in children Patients may have a high fever chills and muscle aches They sometimes can have severe complications that may even result in death
The vaccines in this study are called transmission blocking vaccines These vaccines stimulate the persons immune system to produce antibodies against malaria When a mosquito bites a vaccinated person it ingests some of the persons blood The antibodies in the ingested blood stop the malaria parasite from developing inside the mosquito The mosquito would not be able to transmit malaria to other people PpPfs25ISA51 Vaccine A stimulates production of antibodies against the malaria parasite Plasmodium falciparum and ScPvs25ISA51 Vaccine B stimulates antibodies against the malaria parasite Plasmodium vivax The vaccines also contain a substance called Montanide ISA51 which boosts the immune response to the vaccine
Healthy volunteers between 18 and 50 years of age may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests Women who are able to become pregnant have a urine pregnancy test before each immunization
Participants are randomly assigned to receive two injections spaced 4 months apart of either Vaccine A or Vaccine B at one of three doses-high medium or low Two subjects in each dose group additionally serve as controls and receive only Montanide ISA51 mixed with saline The vaccine is injected into the muscle of the upper arm Subjects are monitored for 30 minutes after each injection for possible side effects and take home a diary card to record their temperature and any symptoms that may appear over the next 13 days
A blood sample is drawn before and on several occasions after each vaccination to check the subjects health and to evaluate the immune response to the vaccine At 1 3 7 14 and 21 days after each vaccination participants come to the clinic for a check of vital signs temperature pulse respiration and blood pressure brief physical examination and history of symptoms since the previous visit
The vaccines in this study are called transmission blocking vaccines These vaccines stimulate the persons immune system to produce antibodies against malaria When a mosquito bites a vaccinated person it ingests some of the persons blood The antibodies in the ingested blood stop the malaria parasite from developing inside the mosquito The mosquito would not be able to transmit malaria to other people PpPfs25ISA51 Vaccine A stimulates production of antibodies against the malaria parasite Plasmodium falciparum and ScPvs25ISA51 Vaccine B stimulates antibodies against the malaria parasite Plasmodium vivax The vaccines also contain a substance called Montanide ISA51 which boosts the immune response to the vaccine
Healthy volunteers between 18 and 50 years of age may be eligible for this study Candidates are screened with a medical history physical examination and blood and urine tests Women who are able to become pregnant have a urine pregnancy test before each immunization
Participants are randomly assigned to receive two injections spaced 4 months apart of either Vaccine A or Vaccine B at one of three doses-high medium or low Two subjects in each dose group additionally serve as controls and receive only Montanide ISA51 mixed with saline The vaccine is injected into the muscle of the upper arm Subjects are monitored for 30 minutes after each injection for possible side effects and take home a diary card to record their temperature and any symptoms that may appear over the next 13 days
A blood sample is drawn before and on several occasions after each vaccination to check the subjects health and to evaluate the immune response to the vaccine At 1 3 7 14 and 21 days after each vaccination participants come to the clinic for a check of vital signs temperature pulse respiration and blood pressure brief physical examination and history of symptoms since the previous visit
Detailed Description:
The purpose of this Phase 1 clinical trial is to evaluate the safety reactogenicity and immunogenicity of two malaria transmission-blocking vaccines PpPfs25 and ScPvs25 in healthy adult volunteers Of the four species of malaria that infect humans Plasmodium falciparum is responsible for the majority of these deaths However outside of Africa most of the malaria is caused by Plasmodium vivax although these cases result in few deaths they represent a major cause of morbidity and lead to a significant impact on the quality of life The development of a safe and effective vaccine that prevents the transmission of P falciparum or P vivax would be an important addition to the current methods for controlling the spread of malaria parasites A vaccine designed to prevent oocyst development in the mosquito by eliciting transmission-blocking antibodies in the vertebrate host would protect other individuals in the vicinity from becoming infected from the immunized person Thus despite no immediate role in personal protection transmission-blocking vaccines are a potentially powerful component of a multifaceted public health approach to controlling or eliminating malaria This study will be conducted at the Johns Hopkins University - Bloomberg School of Public Health Center for Immunization Research Seventy-two healthy male and non-pregnant female volunteers ages 18-50 will be enrolled This study will be single blinded to volunteers and placebo-controlled The study will evaluate three dose levels of both the PpPfs25 and ScPvs25 malaria vaccines 5 microg 20 microg 80 microg emulsified with Montanide ISA51 as compared to Montanide ISA51 given alone Seventy-two volunteers 60 vaccine and 12 placebo will be enrolled and assigned to one of six cohorts In each cohort 10 volunteers will receive vaccine and 2 will receive placebo Volunteers will be vaccinated by intramuscular injection on days 0 and 120 The groups will be staggered such that adequate safety evaluation can be performed prior to dose escalation The duration of the study is 18 months per volunteer The primary objectives of this trial are to assess and compare in a dose-escalating study the safety and reactogenicity of the PpPfs25 and ScPvs25 transmission blocking vaccines as compared to adjuvant alone and to assess and compare in dose-escalating study the duration of the antibody response over an 18 month period in each volunteer as well as the effect of boosting with a second vaccination at 4 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 05-I-0118 | None | None | None |