Vaccine-related Adverse Events
| Group | Value (Participants) |
|---|---|
| 100 µg Na-GST-1/Alhydrogel | 1 |
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 | 3 |
| 100 µg Na-GST-1/Alhydrogel + CpG 10104 | 0 |
Trial · Interventional
CompletedPhase 1Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Na-GST-1 is a protein expressed during the adult stage of the hookworm life cycle that is thought to play a role in the parasite's degradation of host hemoglobin for use as an energy source. Vaccination with recombinant GST-1 has protected dogs and hamsters from infection in challenge studies. This study will evaluate the safety and immunogenicity of two formulations of Na-GST-1 in healthy adult volunteers when co-administered with the immunostimulant CpG 10104, a Toll-like Receptor-9 agonist.
Experimental
100 µg Na-GST-1/Alhydrogel
High Dose Na-GST-1/Alhydrogel® Only
Experimental
30 µg Na-GST-1/Alhydrogel + CpG 10104
Low Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104
Experimental
100 µg Na-GST-1/Alhydrogel + CpG 10104
High Dose Na-GST-1/Alhydrogel® Plus 500 µg CpG 10104
Outcomes the sponsor listed as primary.
Vaccine-related Adverse Events
Time frame · 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
IgG Antibody Response to Na-GST-1 on Study Day 126
Time frame · 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.
Exploratory Cellular Immune Response to Na-GST-1
Time frame · Up to study day 290
Exploratory studies of the cellular immune responses to the Na-GST-1 antigen both before and after immunization.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| 100 µg Na-GST-1/Alhydrogel | 1 |
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 | 3 |
| 100 µg Na-GST-1/Alhydrogel + CpG 10104 | 0 |
| Group | Value (Arbitrary Units/mL) |
|---|---|
| 100 µg Na-GST-1/Alhydrogel | 49.42 |
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 | 300.7 |
| 100 µg Na-GST-1/Alhydrogel + CpG 10104 | 389.5 |
| Group | Value |
|---|---|
| 30 µg Na-GST-1/Alhydrogel + CpG 10104 | not posted |
| 100 µg Na-GST-1/Alhydrogel | not posted |
| 100 µg Na-GST-1/Alhydrogel + CpG 10104 | not posted |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| 100 µg Na-GST-1/AlhydrogelHigh 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. | 0 / 8 | 0 / 8 | 8 / 8 |
| 30 µg Na-GST-1/Alhydrogel + CpG 10104Low 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'. | 0 / 8 | 0 / 8 | 8 / 8 |
| 100 µg Na-GST-1/Alhydrogel + CpG 10104High 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'. | 0 / 8 | 0 / 8 | 8 / 8 |
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