Study: NCT02531802

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: ETVAX
Description: Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:~* Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg~* E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)~* E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)~* E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)~* E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: dmLT
Description: Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water

Intervention type: OTHER
Group type: PLACEBO_COMPARATOR
Intervention: Bicarbonate Buffer
Description: Sodium bicarbonate buffer dissolved in 150 ml of potable water