Trial Outcomes & Findings for Safety and Immunogenicity Study of Na-GST-1 With or Without CpG (NCT NCT02143518)

Last Updated: 2025-07-04

Results Overview

The frequency of immediate, systemic, and local injection site adverse events, graded by severity, for Na-GST-1/Alhydrogel administered alone or in combination with CpG 10104

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Up to study day 470

Results posted on

2025-07-04

Participant Flow

Participant milestones

Participant milestones
Measure	100 µg Na-GST-1/Alhydrogel High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.	30 µg Na-GST-1/Alhydrogel + CpG 10104 Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	100 µg Na-GST-1/Alhydrogel + CpG 10104 High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.
Overall Study STARTED	8	8	8
Overall Study COMPLETED	8	6	7
Overall Study NOT COMPLETED	0	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Immunogenicity Study of Na-GST-1 With or Without CpG

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	100 µg Na-GST-1/Alhydrogel n=8 Participants High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.	30 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 Participants Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	100 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 Participants High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	24 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	26.5 years n=5 Participants	31.0 years n=7 Participants	32 years n=5 Participants	29 years n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	8 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	24 participants n=4 Participants

PRIMARY outcome

Timeframe: Up to study day 470

The frequency of immediate, systemic, and local injection site adverse events, graded by severity, for Na-GST-1/Alhydrogel administered alone or in combination with CpG 10104

Outcome measures

Outcome measures
Measure	100 µg Na-GST-1/Alhydrogel n=8 Participants High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.	30 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 Participants Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	100 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 Participants High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.
Vaccine-related Adverse Events Number of participants with an immediate AE	1 Participants	3 Participants	0 Participants
Vaccine-related Adverse Events Number of participants with a systemic AE	3 Participants	4 Participants	5 Participants
Vaccine-related Adverse Events Number of participants with an injection site AE	7 Participants	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 14 days after final vaccination

Dose and formulation of Na-GST-1 that generates the highest IgG antibody response at Day 126 (14 days after final vaccination), as determined by a qualified indirect enzyme-linked immunosorbent assay (ELISA) and measured in Arbitrary Units (AU) that are interpolated from a standard reference curve formulated by serial dilutions of a serum pool derived from known high responders in previous clinical trials of this antigen. This ELISA has not been validated and does not report mass units since these have not yet been defined. Reporting ELISA values in AU is an accepted practice early in clinical development before full assay validation and quantification of mass units.

Outcome measures

Outcome measures
Measure	100 µg Na-GST-1/Alhydrogel n=8 Participants High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.	30 µg Na-GST-1/Alhydrogel + CpG 10104 n=6 Participants Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	100 µg Na-GST-1/Alhydrogel + CpG 10104 n=7 Participants High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.
IgG Antibody Response to Na-GST-1 on Study Day 126	49.42 Arbitrary Units/mL Interval 17.07 to 143.0	300.7 Arbitrary Units/mL Interval 194.6 to 464.8	389.5 Arbitrary Units/mL Interval 212.8 to 713.0

SECONDARY outcome

Timeframe: Up to study day 290

Population: The data for this endpoint were not collected since PBMC samples were not sent from the clinical trial site in Africa to the testing laboratory in the US due to the ending of the grant funding the study and a lack of funding to ship the samples. This endpoint will not be completed.

Exploratory studies of the cellular immune responses to the Na-GST-1 antigen both before and after immunization.

Outcome measures

Outcome data not reported

Adverse Events

100 µg Na-GST-1/Alhydrogel

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

30 µg Na-GST-1/Alhydrogel + CpG 10104

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

100 µg Na-GST-1/Alhydrogel + CpG 10104

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

David J. Diemert, MD

George Washington University

Phone: 202-994-2909

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	100 µg Na-GST-1/Alhydrogel n=8 participants at risk High Dose Na-GST-1/Alhydrogel® Only Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.	30 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 participants at risk Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.	100 µg Na-GST-1/Alhydrogel + CpG 10104 n=8 participants at risk High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104 Na-GST-1/Alhydrogel®: The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation. CpG 10104: Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Gastrointestinal disorders Abdominal Pain	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	37.5% 3/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Investigations Antinuclear antibody increased	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	75.0% 6/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Musculoskeletal and connective tissue disorders Back Pain	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Investigations Body temperature increased	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Cardiac disorders Bradycardia	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Chest Pain	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Chills	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Injury, poisoning and procedural complications Contusion	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	37.5% 3/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Psychiatric disorders Depression	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Vascular disorders Diastolic hypertension	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Nervous system disorders Dizziness	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Gastrointestinal disorders Dry Mouth	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Skin and subcutaneous tissue disorders Ecchymosis	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Ear and labyrinth disorders Eustachian tube dysfunction	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Injury, poisoning and procedural complications Excoriation	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Eye disorders Eye pain	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Fatigue	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	37.5% 3/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Investigations Haemoglobin decreased	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Injury, poisoning and procedural complications Hand fracture	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Hangover	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Nervous system disorders Headache	62.5% 5/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	62.5% 5/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	62.5% 5/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Influenza like illness	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	25.0% 2/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Injection site coldness	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Injection site erythema	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Injection site pain	87.5% 7/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	100.0% 8/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	87.5% 7/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Injection site pruritus	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
General disorders Injection site swelling	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.
Psychiatric disorders Insomnia	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	12.5% 1/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.	0.00% 0/8 • Participants were followed for approximately 68 weeks, or 16 months. This includes following participants for approximately 12 months after receiving the third vaccination.