Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321061
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-05-02
Brief Title:
Phase I Study of Vaccination Schedule of Experimental HIV Vaccines
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
VRC 011 A Phase I Clinical Trial of Intramuscular Subcutaneous and Intradermal Administration of an HIV-1 Multiclade DNA Vaccine VRC-HIVDNA016-00-VP and an HIV-1 Multiclade Adenoviral Vector VaccineVRC-HIVADV014-00-VP in Uninfected Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2009-12-02
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 will test whether a vaccination schedule of experimental HIV vaccines is safe and whether it causes side effects in healthy adult volunteers It will also compare the effects of vaccine injected into the muscle intramuscular just under the skin subcutaneous or into the skin intradermal and will monitor the social impact of being in an HIV vaccine study
Healthy volunteers 18-50 years old may be eligible for this 42-week study Participants are screened for antibodies to adenovirus a common virus that causes upper respiratory infections such as the common cold Half of the participants selected will be positive and half will be negative for antibodies to the virus
The vaccines used in this study are known as VRC-HIVDNA016-00-VP called the DNA vaccine and VRC-HIVADV014-00-VP called the rAd5 vaccine The DNA vaccine codes for four HIV proteins The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins These vaccines cannot cause HIV or adenoviral infections
Participants are randomly assigned to one of six possible vaccination schedules that include prime and booster vaccines The first vaccinations prime the immune system and the immune response is then boosted later The groups differ in the type of vaccines given DNA vaccine prime with rAd5 booster or rAd5 prime with rAd5 booster in how the vaccine is administered intramuscularly subcutaneously or intradermally and in the schedule of administration All shots are given in the upper arm Subjects fill out a diary card at home for 5 days after each vaccination recording their temperature and any symptoms The cards are turned in to the clinic at the first visit after all 5 days are completed Subjects return for clinic visits about 3 days after each prime vaccination and either come in or call the clinic about 7 days after the injection They call a study nurse 1 or 2 days after the booster vaccination
Participants have 15-20 clinic visits during the course of the study depending on their vaccination schedule At each visit they are checked for health changes or problems asked how they are feeling and if they have taken any medications or other treatments including over-the-counter medicines herbal supplements etc Blood and urine samples are collected at some visits Subjects are tested for HIV several times and asked questions about their sexual behavior and drug use Throughout the stu
Healthy volunteers 18-50 years old may be eligible for this 42-week study Participants are screened for antibodies to adenovirus a common virus that causes upper respiratory infections such as the common cold Half of the participants selected will be positive and half will be negative for antibodies to the virus
The vaccines used in this study are known as VRC-HIVDNA016-00-VP called the DNA vaccine and VRC-HIVADV014-00-VP called the rAd5 vaccine The DNA vaccine codes for four HIV proteins The rAd5 vaccine is made using an adenovirus that has been modified to contain DNA that codes for three HIV proteins These vaccines cannot cause HIV or adenoviral infections
Participants are randomly assigned to one of six possible vaccination schedules that include prime and booster vaccines The first vaccinations prime the immune system and the immune response is then boosted later The groups differ in the type of vaccines given DNA vaccine prime with rAd5 booster or rAd5 prime with rAd5 booster in how the vaccine is administered intramuscularly subcutaneously or intradermally and in the schedule of administration All shots are given in the upper arm Subjects fill out a diary card at home for 5 days after each vaccination recording their temperature and any symptoms The cards are turned in to the clinic at the first visit after all 5 days are completed Subjects return for clinic visits about 3 days after each prime vaccination and either come in or call the clinic about 7 days after the injection They call a study nurse 1 or 2 days after the booster vaccination
Participants have 15-20 clinic visits during the course of the study depending on their vaccination schedule At each visit they are checked for health changes or problems asked how they are feeling and if they have taken any medications or other treatments including over-the-counter medicines herbal supplements etc Blood and urine samples are collected at some visits Subjects are tested for HIV several times and asked questions about their sexual behavior and drug use Throughout the stu
Detailed Description:
STUDY DESIGN
The VRC DNA vaccine and VRC recombinant adenoviral vector rAd5 vaccine have been previously shown to elicit immune responses to HIV-1-specific peptides when administered intramuscularly IM alone and in prime-boost schedules This Phase I randomized open-label exploratory study will evaluate the safety and tolerability and the immune responses when IM subcutaneous SC or intradermal ID routes of administration are used for the priming vaccinations in a prime-boost schedule The randomization will ensure that subjects with negative and positive screening adenovirus type 5 antibody Ad5Ab titers will be equally represented in each prime-boost schedule evaluated in the study Group 1 subjects will receive three DNA prime vaccinations followed by a rAd5 boost vaccination and Group 2 subjects will receive one rAd5 prime vaccination followed by a rAd5 boost vaccination It is also of interest to explore whether vaccination by SC or ID route alters the functional qualities of the immune response About half of the subjects who screen for HIV vaccine studies at the VRC Clinic have negative Ad5Ab titer and half have positive Ad5Ab titers
The hypotheses are 1 IM SC and ID are all safe routes of administration for both the DNA and rAd5 vaccines 2 all regimens will elicit immune responses to HIV-1-specific peptides 3 intradermal administration will allow a lower dosage of the DNA vaccine to be used for eliciting an immune response and 4 rAd5 booster administered after a rAd5 prime will boost the cellular and humoral immune response The primary objectives relate to evaluation of the safety and tolerability of the DNA and rAd5 vaccines when administered by IM SC and ID routes Secondary objectives are related to evaluation of the immunogenicity of the vaccines when administered by SC and ID routes as compared to the IM route and the social impact of participating in an HIV-1 vaccine trial Exploratory evaluations of the immunogenicity of the vaccination regimens are also planned
PROTOCOL DESCRIPTION
VRC-HIVDNA016-00-VP DNA vaccine is composed of 6 closed circular DNA plasmids that encode HIV-1 Gag Pol and Nef from clade B and Env glycoprotein from clade A clade B and clade C each plasmid comprises 1667 percent by weight of the vaccine VRC-HIVADV014-00-VP rAd5 vaccine is composed of 4 recombinant non-replicating adenoviral vectors that encode for HIV-1 GagPol polyproteins from clade B and Env glycoprotein from clade A clade B and clade C which are combined in a 3111 ratio respectively
SUBJECTS
Sixty healthy adult volunteers 18 to 50 years old 30 subjects with negative Ad5Ab titers less than 112 and 30 subjects with positive Ad5Ab titers greater than or equal to 112
STUDY PLAN
Subjects with negative and positive Ad5Ab titers will be equally randomized to the six prime-boost schedules evaluated in the study as shown in the schema below All injections will be administered by a needle and syringe device appropriate for the route of administration specified
The VRC DNA vaccine and VRC recombinant adenoviral vector rAd5 vaccine have been previously shown to elicit immune responses to HIV-1-specific peptides when administered intramuscularly IM alone and in prime-boost schedules This Phase I randomized open-label exploratory study will evaluate the safety and tolerability and the immune responses when IM subcutaneous SC or intradermal ID routes of administration are used for the priming vaccinations in a prime-boost schedule The randomization will ensure that subjects with negative and positive screening adenovirus type 5 antibody Ad5Ab titers will be equally represented in each prime-boost schedule evaluated in the study Group 1 subjects will receive three DNA prime vaccinations followed by a rAd5 boost vaccination and Group 2 subjects will receive one rAd5 prime vaccination followed by a rAd5 boost vaccination It is also of interest to explore whether vaccination by SC or ID route alters the functional qualities of the immune response About half of the subjects who screen for HIV vaccine studies at the VRC Clinic have negative Ad5Ab titer and half have positive Ad5Ab titers
The hypotheses are 1 IM SC and ID are all safe routes of administration for both the DNA and rAd5 vaccines 2 all regimens will elicit immune responses to HIV-1-specific peptides 3 intradermal administration will allow a lower dosage of the DNA vaccine to be used for eliciting an immune response and 4 rAd5 booster administered after a rAd5 prime will boost the cellular and humoral immune response The primary objectives relate to evaluation of the safety and tolerability of the DNA and rAd5 vaccines when administered by IM SC and ID routes Secondary objectives are related to evaluation of the immunogenicity of the vaccines when administered by SC and ID routes as compared to the IM route and the social impact of participating in an HIV-1 vaccine trial Exploratory evaluations of the immunogenicity of the vaccination regimens are also planned
PROTOCOL DESCRIPTION
VRC-HIVDNA016-00-VP DNA vaccine is composed of 6 closed circular DNA plasmids that encode HIV-1 Gag Pol and Nef from clade B and Env glycoprotein from clade A clade B and clade C each plasmid comprises 1667 percent by weight of the vaccine VRC-HIVADV014-00-VP rAd5 vaccine is composed of 4 recombinant non-replicating adenoviral vectors that encode for HIV-1 GagPol polyproteins from clade B and Env glycoprotein from clade A clade B and clade C which are combined in a 3111 ratio respectively
SUBJECTS
Sixty healthy adult volunteers 18 to 50 years old 30 subjects with negative Ad5Ab titers less than 112 and 30 subjects with positive Ad5Ab titers greater than or equal to 112
STUDY PLAN
Subjects with negative and positive Ad5Ab titers will be equally randomized to the six prime-boost schedules evaluated in the study as shown in the schema below All injections will be administered by a needle and syringe device appropriate for the route of administration specified
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 |
|---|---|---|---|
| 06-I-0149 | None | None | None |