Trial Outcomes & Findings for The Interaction Between Measles and DTP Vaccination (NCT NCT02710045)
NCT ID: NCT02710045
Last Updated: 2019-01-28
Results Overview
The IFN-gamma:IL-4 cytokine ratio in plasma samples taken 4 weeks after vaccination measured by multiplex assay using the Bio-Plex 200 Suspension Array system. Ratio compared between the 3 intervention groups with the hypothesis that the MV+DTP group will have a higher ratio than the other 2 groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
302 participants
Primary outcome timeframe
4 weeks after vaccination
Results posted on
2019-01-28
Participant Flow
Participant milestones
| Measure |
MV at 9 Months
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Overall Study
STARTED
|
106
|
115
|
81
|
|
Overall Study
COMPLETED
|
95
|
98
|
68
|
|
Overall Study
NOT COMPLETED
|
11
|
17
|
13
|
Reasons for withdrawal
| Measure |
MV at 9 Months
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
7
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Poor Attendance
|
0
|
1
|
0
|
Baseline Characteristics
The Interaction Between Measles and DTP Vaccination
Baseline characteristics by cohort
| Measure |
MV at 9 Months
n=106 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=115 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=81 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
125 days
STANDARD_DEVIATION 8 • n=5 Participants
|
124 days
STANDARD_DEVIATION 7 • n=7 Participants
|
124 days
STANDARD_DEVIATION 7 • n=5 Participants
|
124 days
STANDARD_DEVIATION 7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group of Mother · Mandinka
|
80 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group of Mother · Wolof
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group of Mother · Fula
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group of Mother · Jola
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnic Group of Mother · Other
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Region of Enrollment
Gambia
|
106 participants
n=5 Participants
|
115 participants
n=7 Participants
|
81 participants
n=5 Participants
|
302 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after vaccinationPopulation: Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
The IFN-gamma:IL-4 cytokine ratio in plasma samples taken 4 weeks after vaccination measured by multiplex assay using the Bio-Plex 200 Suspension Array system. Ratio compared between the 3 intervention groups with the hypothesis that the MV+DTP group will have a higher ratio than the other 2 groups.
Outcome measures
| Measure |
MV at 9 Months
n=76 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=78 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=53 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect on Interferon (IFN)-Gamma : Interleukin (IL)-4 Ratio in Plasma
|
1.48 ratio of cytokines in pg/mL
Standard Deviation 1.41
|
1.44 ratio of cytokines in pg/mL
Standard Deviation 1.44
|
0.46 ratio of cytokines in pg/mL
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: 4 weeks (9 months and 10 months of age)Population: Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
Regulatory T cell (Treg) frequencies (among all gated CD4+ T cells) at 9 and 10 months of age determined by flow cytometry and compared between the 3 intervention groups with the primary hypothesis that the MV+DTP group will have lower Treg frequencies than the MV group.
Outcome measures
| Measure |
MV at 9 Months
n=68 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=77 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=49 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect on CD4+FOXP3+CD127- Regulatory T Cell Frequencies
9 month values
|
5.84 Percentage of CD4+ T cells
Standard Deviation 2.24
|
4.94 Percentage of CD4+ T cells
Standard Deviation 2.24
|
5.86 Percentage of CD4+ T cells
Standard Deviation 1.82
|
|
Effect on CD4+FOXP3+CD127- Regulatory T Cell Frequencies
10 month values
|
6.71 Percentage of CD4+ T cells
Standard Deviation 4.68
|
5.38 Percentage of CD4+ T cells
Standard Deviation 1.87
|
4.85 Percentage of CD4+ T cells
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: 4 weeks (9 and 10 months of age)Population: Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
Effect of combining MV and DTP on measles antibody responses to see if combining vaccines interferes with antibody generation. Plasma measles antibodies measured by haemagglutination inhibition assay at 9 and 10 months of age.
Outcome measures
| Measure |
MV at 9 Months
n=100 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=110 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=73 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect of Vaccine Group on Measles Antibody Levels
Value at 9 months of age
|
0.29 Haemagglutination titre
Standard Deviation 0.94
|
0.21 Haemagglutination titre
Standard Deviation 0.72
|
0.3 Haemagglutination titre
Standard Deviation 0.96
|
|
Effect of Vaccine Group on Measles Antibody Levels
Value at 10 months of age
|
5.28 Haemagglutination titre
Standard Deviation 2.27
|
5.52 Haemagglutination titre
Standard Deviation 2.18
|
0.37 Haemagglutination titre
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 4 weeks (9 and 10 months of age)Population: Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
CD4+CD45RO+CD62L- effector memory T cells measured by flow cytometry at 9 and 10 months of age
Outcome measures
| Measure |
MV at 9 Months
n=83 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=91 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=56 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect of Vaccine Group on Effector Memory T Cells (TEM)
TEM at 9 months of age
|
3.54 Percent of all CD4+ T cells
Standard Deviation 4.03
|
2.67 Percent of all CD4+ T cells
Standard Deviation 2.42
|
3.10 Percent of all CD4+ T cells
Standard Deviation 2.90
|
|
Effect of Vaccine Group on Effector Memory T Cells (TEM)
TEM at 10 months of age
|
4.50 Percent of all CD4+ T cells
Standard Deviation 5.02
|
5.27 Percent of all CD4+ T cells
Standard Deviation 7.91
|
4.52 Percent of all CD4+ T cells
Standard Deviation 6.62
|
SECONDARY outcome
Timeframe: 4 weeks (9 and 10 months of age)Population: Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
Plasma diphtheria and tetanus toxoid antibodies were measured by multiplex microsphere-based fluorescent immunoassay at 9 and 10 months of age.
Outcome measures
| Measure |
MV at 9 Months
n=100 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=110 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=74 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels
Tetanus toxoid antibodies at 9 months
|
0.62 IU/mL
Standard Deviation 0.63
|
0.80 IU/mL
Standard Deviation 0.78
|
0.86 IU/mL
Standard Deviation 0.90
|
|
Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels
Tetanus antibodies toxoid at 10 months
|
0.87 IU/mL
Standard Deviation 1.02
|
5.45 IU/mL
Standard Deviation 6.24
|
6.46 IU/mL
Standard Deviation 5.42
|
|
Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels
Diphtheria toxoid antibodies at 9 months
|
0.14 IU/mL
Standard Deviation 0.16
|
0.07 IU/mL
Standard Deviation 0.10
|
0.13 IU/mL
Standard Deviation 0.41
|
|
Effect of Vaccine Group on Diphtheria and Tetanus Antibody Levels
Diphtheria toxoid antibodies at 10 months
|
0.23 IU/mL
Standard Deviation 0.50
|
1.79 IU/mL
Standard Deviation 3.02
|
1.57 IU/mL
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: 4 weeks (9 and 10 months of age)Population: Study infants at 9 and 10 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
Plasma pertussis toxoid antibodies were measured by multiplex microsphere-based fluorescent immunoassay at 9 and 10 months of age
Outcome measures
| Measure |
MV at 9 Months
n=100 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=110 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=74 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Effect of Vaccine Group on Pertussis Toxoid Antibody Levels
Pertussis toxoid antibodies at 9 months
|
18.30 EU/mL
Standard Deviation 36.11
|
10.68 EU/mL
Standard Deviation 32.15
|
11.11 EU/mL
Standard Deviation 37.18
|
|
Effect of Vaccine Group on Pertussis Toxoid Antibody Levels
Pertussis toxoid antibodies at 10 months
|
18.91 EU/mL
Standard Deviation 42.31
|
103.72 EU/mL
Standard Deviation 149.94
|
86.96 EU/mL
Standard Deviation 117.44
|
SECONDARY outcome
Timeframe: 10 months (19 months of age)Population: Study children at 19 months of age. Not all participants had this assay done due to the follow reasons: failure to attend the appointment, unwell on the day of follow up, dropped out of the study, assay failure, insufficient blood sample volume or quality.
Measles antibody levels were measured by haemagglutination inhibition assay (HAI) at 19 months of age, 4 weeks after MV challenge at 18 months of age. The aim was to determine whether the vaccination schedule at 9 months of age altered responses to a subsequent MV challenge at 18 months of age i.e., the antibody measurement was made 10 months after the first study intervention.
Outcome measures
| Measure |
MV at 9 Months
n=75 Participants
All vaccines given as per normal Gambia schedule until 9 months of age, including third dose of diphtheria-tetanus-whole cell pertussis (DTP3), hepatitis B vaccine (HBV) and oral polio vaccine (OPV) at four months of age.
At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
DTP + MV at 9 Months
n=78 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given a single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid, and i.m. DTP (Serum Institute of India Ltd.) in the thigh. Yellow fever vaccine (YF) and OPV administered at 11 months of age. Given a standard MV challenge at 18 months old.
Measles Vaccine at 9 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the de
|
DTP at 9 Months
n=60 Participants
DTP3 dose withheld and given HBV and OPV at four months of age. At 9 months of age given i.m. DTP (Serum Institute of India Ltd.) in the thigh. MV, OPV and YF administered at 11 months of age. Given a standard MV challenge at 18 months of age.
Diphtheria-tetanus-whole cell pertussis vaccine at 9 months of age: Single intramuscular (i.m.) dose of DTP (Serum Institute of India Ltd.) into the thigh at 9 months of age
Measles Vaccine at 18 months of age: Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
|
|---|---|---|---|
|
Measles Antibody Levels at 19 Months of Age
|
7.74 HAI titre
Standard Deviation 1.67
|
7.47 HAI titre
Standard Deviation 2.40
|
7.69 HAI titre
Standard Deviation 1.25
|
Adverse Events
MV Vaccination at 9 Months
Serious events: 1 serious events
Other events: 88 other events
Deaths: 1 deaths
DTP and MV Vaccination at 9 Months
Serious events: 0 serious events
Other events: 90 other events
Deaths: 2 deaths
DTP Vaccination at 9 Months
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MV Vaccination at 9 Months
n=106 participants at risk
Infants administered MV at 9 months of age
|
DTP and MV Vaccination at 9 Months
n=115 participants at risk
Infants administered MV and DTP vaccines at 9 months of age
|
DTP Vaccination at 9 Months
n=81 participants at risk
Infants administered DTP vaccine at 9 months of age
|
|---|---|---|---|
|
Infections and infestations
Hospital admission with fever and rash
|
0.94%
1/106 • Number of events 1 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
0.00%
0/115 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
0.00%
0/81 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
Other adverse events
| Measure |
MV Vaccination at 9 Months
n=106 participants at risk
Infants administered MV at 9 months of age
|
DTP and MV Vaccination at 9 Months
n=115 participants at risk
Infants administered MV and DTP vaccines at 9 months of age
|
DTP Vaccination at 9 Months
n=81 participants at risk
Infants administered DTP vaccine at 9 months of age
|
|---|---|---|---|
|
Infections and infestations
Fever
|
17.9%
19/106 • Number of events 25 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
20.9%
24/115 • Number of events 30 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
14.8%
12/81 • Number of events 16 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
|
Respiratory, thoracic and mediastinal disorders
Chest infection
|
57.5%
61/106 • Number of events 132 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
66.1%
76/115 • Number of events 179 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
59.3%
48/81 • Number of events 99 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
|
Skin and subcutaneous tissue disorders
Rash, sores
|
32.1%
34/106 • Number of events 48 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
31.3%
36/115 • Number of events 49 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
35.8%
29/81 • Number of events 35 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
|
Gastrointestinal disorders
Diarrhoea and / or vomiting
|
52.8%
56/106 • Number of events 97 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
55.7%
64/115 • Number of events 106 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
45.7%
37/81 • Number of events 77 • 10 months (from 9 months of age to 19 months of age)
Infants were followed up monthly for 10 months and a clinical questionnaire was completed at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place